Pharmaceutical production system and method

文档序号：199042 发布日期：2021-11-05 浏览：47次中文

阅读说明：本技术 制药生产系统和方法 (Pharmaceutical production system and method ) 是由付小龙蒋云郝国舜刘兵于 2021-07-19 设计创作，主要内容包括：本发明公开了制药生产系统和方法。其中,制药生产系统包括：生产辅助区、生产区和中间通道。生产辅助区包括配液间、物料存放间、密封箱清洁间、废料处理间；生产区包括至少一个生产车间；通道设在生产辅助区与生产区之间,并将生产辅助区与生产区隔开；通道通过多个可开闭的通道接口与生产辅助区和生产区连通,通道中具有用于生产辅助区与生产区之间物流的物料密封箱和废料密封箱,物料密封箱和废料密封箱具有与通道接口相适配的密封箱接口。该制药生产系统可以有效、高效地实现多批次产品的共线生产,并解决各生产区域交叉污染的问题,适应产品定制化生产的需求。(The invention discloses a pharmaceutical production system and a method. Wherein, the pharmacy production system includes: a production auxiliary zone, a production zone and an intermediate channel. The production auxiliary area comprises a liquid preparation room, a material storage room, a sealed box cleaning room and a waste treatment room; the production area comprises at least one production workshop; the channel is arranged between the production auxiliary area and the production area and separates the production auxiliary area from the production area; the channel is communicated with the production auxiliary area and the production area through a plurality of openable channel interfaces, a material sealing box and a waste sealing box which are used for logistics between the production auxiliary area and the production area are arranged in the channel, and the material sealing box and the waste sealing box are provided with sealing box interfaces matched with the channel interfaces. The pharmaceutical production system can effectively and efficiently realize the collinear production of a plurality of batches of products, solves the problem of cross contamination of each production area, and meets the requirement of customized production of the products.)

1. A pharmaceutical production system, comprising:

the production auxiliary area comprises a liquid preparation room, a material storage room, a seal box cleaning room and a waste treatment room;

a production area comprising at least one production plant;

a passage provided between the production sub-zone and the production zone and separating the production sub-zone from the production zone; the channel is communicated with the production auxiliary area and the production area through a plurality of openable channel interfaces, a material sealing box and a waste sealing box which are used for logistics transportation between the production auxiliary area and the production area are arranged in the channel, and the material sealing box and the waste sealing box are provided with sealing box interfaces matched with the channel interfaces;

wherein, at least C-grade GMP cleanliness is arranged in the production auxiliary area, the production area and the channel.

2. The pharmaceutical production system of claim 1, wherein the channel interface is an electromagnetic pull-in aseptic sealed rapid transfer valve; the electromagnetic attraction type sterile sealing quick transfer valve is used for butting the material seal box and the waste material seal box with the production auxiliary area and the production area; the production auxiliary area and the wall of the production area are provided with a first interface; the aseptic sealed fast transfer valve of electromagnetism actuation formula includes:

the main valve component comprises a main valve, an electromagnetic actuator and an electric contact; the main valve is rotatably arranged on the inner side wall of the wall body of the first port so as to open and close the production auxiliary area or the production area, and when the main valve is in a closed state, the main valve is connected with the wall body in a sealing way; the electric contact is arranged on the outer side wall of the wall body; the electromagnetic actuator is arranged on the main valve;

an auxiliary valve assembly including an auxiliary valve and a moving valve; the auxiliary valve is fixed on the material seal box or the waste seal box and is provided with a second interface communicated with the material seal box or the waste seal box; the moving valve has a first position and a second position, when the moving valve is in the first position, the moving valve is located in the second interface and a locking seal is formed between the moving valve and the secondary valve; when the moving valve is in the second position, the moving valve is located within the main valve and a locking seal is formed between the moving valve and the main valve.

3. The pharmaceutical production system of claim 2, wherein the main valve includes a main valve body and a first interface end located on a side of the main valve body and defining a cavity with the main valve body; the auxiliary valve comprises a second butt joint end and a third butt joint end which are connected with each other, the second butt joint end is used for butt joint with the outer side wall of the wall body, and the third butt joint end is used for butt joint with the first butt joint end; when the second butt joint end is in butt joint with the outer side wall of the wall body, the third butt joint end is in butt joint with the first butt joint end and is located in the first interface, so that the cavity is connected with the second interface, and the inner peripheral wall of the cavity is flush with the inner peripheral wall of the second interface; the second position of the moving valve is located in the cavity.

4. The electromagnetic attraction-type aseptic sealed rapid transfer valve of claim 3, wherein the main valve assembly further comprises one or more position detection modules for detecting whether the movable valve reaches the first position to ensure a locking seal between the movable valve and the secondary valve, and for detecting whether the movable valve reaches the second position to ensure a locking seal between the movable valve and the inner peripheral wall of the cavity.

5. The electromagnetic attraction type sterile sealing rapid transfer valve according to claim 4, wherein the position detection module comprises a spring and a position contact sensor, one end of the spring is connected to the main valve body and located at the concave bottom of the cavity, the other end of the spring is connected with the position contact sensor, and the position contact sensor is connected with the movable valve.

6. The pharmaceutical production system of claim 1, wherein the channel interface that communicates the production shop with the channel comprises a material interface and a waste interface, the material interface is configured to interface with the material seal box, and the waste interface is configured to interface with the waste seal box;

optionally, a transfer room is arranged in the production workshop, and the channel interface is communicated with the transfer room.

7. The pharmaceutical production system of claim 1, wherein the channel interface communicating the seal box cleaning compartment with the channel comprises a material box cleaning interface and a waste box cleaning interface, the material box cleaning interface is configured to interface with the material seal box, and the waste box cleaning interface is configured to interface with the waste seal box.

8. The pharmaceutical production system of claim 1, further comprising a seal box storage compartment between the seal box clean room and the passageway, the seal box storage compartment being in communication with the seal box clean room through an openable and closable interface or door.

9. The pharmaceutical production system of claim 8, wherein the sealed-box storage room comprises a material sealed-box storage room and a waste sealed-box storage room, and the waste sealed-box cleaning room is communicated with the waste treatment room through an openable and closable interface or door.

10. The pharmaceutical production system of claim 1, wherein the passageways comprise an upper passageway and a lower passageway, the material containment box and the waste containment box being disposed in the upper passageway or the lower passageway, respectively;

optionally, the pharmaceutical production system further comprises: raw material warehouse, detection laboratory and finished product warehouse.

11. A method of pharmaceutical production implemented using the pharmaceutical production system of any of claims 1 to 10, comprising:

the material sealing box is butted with a channel interface between a liquid preparation room or a material storage room in the production auxiliary area, and production materials are provided for the material sealing box;

butting the material seal box containing the production material with a material interface of a production workshop in a production area, and providing the production material into the production workshop; then the material seal box discharging the production materials is butted with a material box cleaning interface between seal box cleaning rooms in the production auxiliary area, and the material seal box is sterilized and cleaned;

butting a waste sealing box with a waste interface of a production workshop in a production area, and providing production waste into the waste sealing box;

butting the waste seal box filled with the production waste with a channel interface of a waste treatment room in the production auxiliary area, and discharging the production waste to the waste treatment room; and then the waste seal box discharging the production waste is butted with a waste box cleaning interface of a seal box cleaning room in the auxiliary production area, and the waste seal box is sterilized and cleaned.

12. The pharmaceutical manufacturing method of claim 11, wherein after the sterilization and cleaning process, the material or waste containment boxes are transferred to a containment box storage compartment for temporary storage and returned to a ready state.

13. The pharmaceutical manufacturing method of claim 11, further comprising: according to the body of the material seal box or the waste seal box and the content of the body, the state of the material seal box or the waste seal box is controlled and tracked, and the transported content is coded, so that the information of the material seal box or the waste seal box is controlled and tracked.

14. The method of claim 13, wherein the material containment or waste containment is externally affixed with a uniquely identifying code, and wherein the flow of the containment is controlled and tracked by scanning the code;

optionally, when the materials are put into the material sealing box, scanning the identification codes of the materials, and then putting the materials into the box body; the system binds the material with the box body through the code scanning action, and then realizes the control and tracking of the material through the flow control and tracking of the material sealing box;

optionally, when the waste is put into the waste sealing box, scanning the identification code of the waste and then putting the waste into the box body; the system binds the waste material with the box body through the code scanning action, and then realizes the control and tracking of the waste material through the flow control and tracking of the waste material sealing box.

Technical Field

The invention relates to the technical field of production and processing, in particular to a pharmaceutical production system and method.

Background

Cell gene therapy is a promising therapeutic strategy that produces customized therapeutic agents for each individual patient's genes and cells. Because of this customization feature, a manufacturing facility for cellular gene therapy drugs is required, and customized production for each patient must be provided.

This new pharmaceutical model places new demands on biopharmaceutical factories, which require both customized and industrial production. In brief, there is a need for a pharmaceutical factory having a mode of producing only one drug per production line, which is different from the conventional pharmaceutical factory, which requires the capability of multiple production lines to simultaneously achieve co-linear production of multiple batches of drugs, and which can rapidly perform batch switching on all production lines.

The two core requirements of multi-batch collinear production and rapid batch switching are that the air environments among different production lines of a cell gene pharmaceutical factory are thoroughly isolated, cross contamination cannot be generated in the material distribution process, equipment of the production lines can be rapidly switched, and the environments of other production lines cannot be influenced when waste materials are removed. This is still a very emerging topic in the biopharmaceutical field.

In the prior art, a plurality of different medicine production lines are physically separated and respectively arranged between materials for parallel production. However, this conventional production method is obviously not suitable for the demand of rapid flow-line production of cell gene drugs characterized by customization, small-lot production and multiple batches, and therefore, it is a current situation that cell gene therapy drugs are extremely expensive. It can be seen that the existing pharmaceutical production systems still need to be developed.

Disclosure of Invention

The present invention is directed to solving, at least to some extent, one of the technical problems in the related art. To this end, an object of the present invention is to propose a pharmaceutical production system, and a pharmaceutical production method implemented using the system. The pharmaceutical production system can effectively and efficiently realize collinear production of a plurality of batches of products, solves the problem of cross contamination of various production areas possibly caused in the material transportation link, and meets the requirement of customized production of the products.

In one aspect of the invention, a pharmaceutical production system is provided. According to an embodiment of the present invention, the pharmaceutical production system comprises:

the production auxiliary area comprises a liquid preparation room, a material storage room, a seal box cleaning room and a waste treatment room;

a production area comprising at least one production plant;

wherein, at least C-grade GMP cleanliness is arranged in the production auxiliary area, the production area and the channel.

According to the pharmaceutical production system provided by the embodiment of the invention, the production auxiliary area and the production area are isolated through the intermediate channel, and the transportation of production materials and production wastes between the production auxiliary area and the production area is realized through the seal box, so that the separation of people flow and logistics is realized, and the cross contamination among the areas is avoided. In some embodiments of the invention, workers and materials are entered into the system using different elevators or corridors, respectively, and the workers disposed in the production auxiliary area and the production area are separated by intermediate passages without cross-contamination between each other.

Specifically, after the production raw materials are prepared by workers in the production auxiliary area, the material seal box is in butt joint with a channel interface between the liquid preparation room and the material storage room, at the moment, the liquid preparation room or the material storage room is communicated with the material seal box, but the material storage room is not further communicated with an intermediate channel, so that gas in the liquid preparation room or the material storage room cannot exchange with gas in the intermediate channel, and possible pollution is avoided. After the production raw materials are placed into the material sealing box, the channel interface and the sealing box interface are closed, the sealing box is in a sealing state, and the materials cannot be polluted. Subsequently, the seal box filled with the production materials is butted with a preset channel interface of a production workshop, at the moment, the current production workshop is communicated with the material seal box, but gas exchange cannot occur with the intermediate channel, and therefore mutual pollution cannot occur between the current production workshop and the intermediate channel. After the staff in the workshop takes out the material, the channel interface is closed with the seal box interface, and the material seal box is sent to the channel interface butt joint with the seal box clean room, accomplishes the cleaning treatment in order to eliminate the pollution that may cause by the workshop.

In summary, according to the pharmaceutical production system provided by the embodiment of the invention, on the basis of ensuring physical isolation among a plurality of production workshops, it can be ensured that gas in a workshop cannot leak out to pollute a public area or other workshops in the process of conveying materials to a certain workshop, and that gas and waste in the workshop cannot generate pollutants to leak out to pollute the public area or other workshops in the process of conveying waste materials outwards in a certain workshop, so that a solution to the most core cross-contamination problem of multi-product collinear production in the pharmaceutical production industry is provided. The pharmaceutical production system of the invention distinguishes the clean material system and the factory production system in two mutually independent dimensions, and after the existing solidified clean material system solves the problem of cross contamination, the factory design can concentrate on the requirements of the production process, and lays a foundation for the pharmaceutical production system based on modularization. In addition, the design scheme that the middle channel carries out multi-batch collinear production has sufficient flexible expansion and quick replication capacity, when a large-scale factory needs to be designed, only more production workshops need to be expanded along two sides of the channel, the clean material mode and the production mode are kept unchanged, and multi-batch collinear production can still be carried out on the premise of ensuring no cross contamination.

In addition, the pharmaceutical production system according to the above embodiment of the present invention may further have the following additional technical features:

in some embodiments of the present invention, the channel interface is an electromagnetic attraction type aseptic sealed rapid transit valve; the electromagnetic attraction type sterile sealing quick transfer valve is used for butting the material seal box and the waste material seal box with the production auxiliary area and the production area; the production auxiliary area and the wall of the production area are provided with a first interface; the aseptic sealed fast transfer valve of electromagnetism actuation formula includes:

In some embodiments of the invention, the main valve comprises a main valve body and a first butt end, the first butt end is located on one side surface of the main valve body and defines a cavity together with the main valve body; the auxiliary valve comprises a second butt joint end and a third butt joint end which are connected with each other, the second butt joint end is used for butt joint with the outer side wall of the wall body, and the third butt joint end is used for butt joint with the first butt joint end; when the second butt joint end is in butt joint with the outer side wall of the wall body, the third butt joint end is in butt joint with the first butt joint end and is located in the first interface, so that the cavity is connected with the second interface, and the inner peripheral wall of the cavity is flush with the inner peripheral wall of the second interface; the second position of the moving valve is located in the cavity.

In some embodiments of the invention, the electromagnetic actuator is mounted on the main valve body at the concave bottom of the cavity.

In some embodiments of the present invention, the main valve assembly further comprises a first seal ring mounted on an inner peripheral wall of the first port; when the main valve is in a closed state, the end face of the first butt end of the main valve is connected with the first sealing ring in a sealing mode.

In some embodiments of the present invention, the main valve assembly further comprises a second sealing ring mounted on an inner sidewall of the wall; when the main valve is in a closed state, the main valve is also connected with the second sealing ring in a sealing mode.

In some embodiments of the present invention, the main valve assembly further comprises a third seal ring mounted on the inner peripheral wall of the cavity; when the moving valve moves to the second position and is locked, the moving valve is in sealing connection with the third sealing ring.

In some embodiments of the invention, the sealing interface of the transfer valve with the third sealing ring is a beveled surface.

In some embodiments of the present invention, the main valve assembly further comprises one or more position detection modules for detecting whether the moving valve reaches the first position to ensure a locking seal between the moving valve and the secondary valve, and for detecting whether the moving valve reaches the second position to ensure a locking seal between the moving valve and an inner peripheral wall of the cavity.

In some embodiments of the present invention, the position detection module includes a spring and a position contact sensor, one end of the spring is connected to the main valve body and located at the concave bottom of the concave cavity, the other end of the spring is connected to the position contact sensor, and the position contact sensor is connected to the moving valve.

In some embodiments of the present invention, the main valve assembly further comprises a rotating shaft installed on an inner sidewall of the wall body, and the main valve is installed on the rotating shaft.

In some embodiments of the present invention, the secondary valve assembly further comprises a fourth seal ring mounted on an inner peripheral wall of the first port; when the second butt joint end is in butt joint with the outer side wall of the wall body, the end face of the third butt joint end is connected with the fourth sealing ring in a sealing mode.

In some embodiments of the present invention, the secondary valve assembly further comprises a second latch mechanism comprising a third latch hook mounted on an outer sidewall of the wall and a fourth latch hook formed on the second butt end; when the second butt joint end is butted on the outer side wall of the wall body, the electric control module controls the third lock hook to hook the fourth lock hook tightly so as to lock the auxiliary valve, so that the end face of the third butt joint end is connected with the fourth sealing ring in a sealing manner; when the material seal box and the waste seal box do not need to be in butt joint with the production auxiliary area or the production area, the electric control module controls the third locking hook to extend out, so that the third locking hook and the fourth locking hook are loosened.

In some embodiments of the invention, the secondary valve assembly comprises a fifth seal ring mounted on an inner peripheral wall of the second port; when the moving valve moves to the first position and is locked, the moving valve is in sealing connection with the fifth sealing ring.

In some embodiments of the present invention, the sealing interface of the moving valve and the fifth sealing ring is a bevel.

In some embodiments of the present invention, the sub-valve assembly further comprises a third locking mechanism comprising a fifth locking hook mounted on an inner circumferential wall of the second port and a sixth locking hook formed on the moving valve; when the movable valve is located at the first position, the electronic control module controls the fifth locking hook to hook the sixth locking hook tightly so as to lock the movable valve, so that the movable valve is in sealing connection with the fifth sealing ring; when the movable valve needs to move to the second position, the electronic control module controls the fifth locking hook to extend out, so that the fifth locking hook and the sixth locking hook are loosened.

In some embodiments of the invention, the secondary valve assembly further comprises a sixth sealing ring disposed on the peripheral wall of the travel valve; when the moving valve moves between the first position and the second position, the sixth sealing ring seals the peripheral wall of the moving valve and the peripheral wall of the first interface opposite to the peripheral wall of the moving valve or the peripheral wall of the cavity.

In some embodiments of the present invention, at least class C GMP cleanliness (e.g., class C, class B, or class a GMP cleanliness) is provided in the production support zone, the production zone, or the tunnel.

In some embodiments of the present invention, the channel interface for communicating the production plant with the channel comprises a material interface and a waste interface, the material interface is used for being in butt joint with the material seal box, and the waste interface is used for being in butt joint with the waste seal box.

In some embodiments of the present invention, a transfer room is provided in the production shop, and the channel interface is communicated with the transfer room.

In some embodiments of the invention, the channel interface connecting the seal box cleaning room and the channel comprises a material box cleaning interface and a waste box cleaning interface, the material box cleaning interface is used for being in butt joint with the material seal box, and the waste box cleaning interface is used for being in butt joint with the waste seal box.

In some embodiments of the present invention, the seal box cleaning room and the passage further include a seal box storage room therebetween, and the seal box storage room is communicated with the seal box cleaning room through an openable and closable interface or door.

In some embodiments of the invention, the seal box storage room comprises a material seal box storage room and a waste seal box storage room, and the waste seal box cleaning room is communicated with the waste treatment room through an openable and closable interface or door.

In some embodiments of the invention, the channel comprises an upper channel and a lower channel, and the material seal box and the waste seal box are respectively arranged in the upper channel or the lower channel.

In some embodiments of the invention, the pharmaceutical production system further comprises: raw material warehouse, detection laboratory and finished product warehouse.

In another aspect of the present invention, the present invention provides a pharmaceutical production method implemented by using the pharmaceutical production system of the above embodiment. According to an embodiment of the invention, the pharmaceutical production method comprises:

butting a waste sealing box with a waste interface of a production workshop in a production area, and providing production waste into the waste sealing box;

According to the pharmaceutical production method of the embodiment of the invention, after the preparation of the production raw materials is completed by the staff in the production auxiliary area, the material seal box is in butt joint with the channel interface between the liquid preparation room or the material storage room, and at the moment, the liquid preparation room or the material storage room is communicated with the material seal box but is not further communicated with the intermediate channel, so that the gas in the liquid preparation room or the material storage room cannot pollute the intermediate channel. After the production raw materials are placed into the material sealing box, the channel interface and the sealing box interface are closed, the sealing box is in a sealing state, and the materials in the sealing box can not pollute the middle channel. Subsequently, the seal box filled with the production materials is butted with a preset channel interface of a production workshop, at the moment, the current production workshop is communicated with the material seal box but cannot be further communicated to the intermediate channel, and therefore, the gas in the current production workshop cannot pollute the intermediate channel. After the staff in the workshop takes out the material, access interface and seal box interface are closed, and the material seal box is sent to and is docked with the access interface between the seal box cleaning room to accomplish cleaning treatment.

When production waste is required to be discharged in a certain production workshop, the waste sealing box is in butt joint with the channel interface of the production workshop, after production waste is filled into the waste sealing box by a worker, the channel interface and the sealing box interface are closed, and the sealing box is in a sealing state. And subsequently, the seal box filled with the production waste is delivered to be in butt joint with a channel interface of a waste treatment room, the waste is discharged, and then the seal box is delivered to be in butt joint with a channel interface of a seal box cleaning room, and the cleaning treatment is completed. The pharmaceutical production system of the invention distinguishes the clean material system and the factory production system in two mutually independent dimensions, and after the existing solidified clean material system solves the problem of cross contamination, the factory design can concentrate on the requirements of the production process, and lays a foundation for the pharmaceutical production system based on modularization. In addition, the design scheme that the middle channel carries out multi-batch collinear production has sufficient flexible expansion and quick replication capacity, when a large-scale factory needs to be designed, only more production workshops need to be expanded along two sides of the channel, the clean material mode and the production mode are kept unchanged, and multi-batch collinear production can still be carried out on the premise of ensuring no cross contamination.

In summary, according to the pharmaceutical production method of the embodiment of the invention, by adopting the pharmaceutical production system of the above embodiment, on the basis of ensuring physical isolation among a plurality of production workshops, it can be ensured that gas in a workshop cannot leak out to pollute a public area or other workshops during the process of transporting materials to a certain workshop, and that gas and waste in the workshop cannot generate pollutants to leak to pollute the public area or other workshops during the process of transporting waste materials outwards in a certain workshop, thereby providing a solution to the most core cross-contamination problem of multi-product collinear production in the pharmaceutical production industry.

In addition, the pharmaceutical production method according to the above embodiment of the present invention may further have the following additional technical features:

in some embodiments of the invention, after the sterilization and cleaning process, the material or waste containment is transferred to a containment storage compartment for temporary storage and returned to a ready state.

In some embodiments of the present invention, the pharmaceutical production method further comprises: and coding the material seal box or the waste seal box according to the body of the material seal box or the waste seal box and the content of the body, so as to control and track the state of the material seal box or the waste seal box and control and track the information of the transported content.

In some embodiments of the invention, the material seal or the waste seal is externally affixed with a uniquely identified identification code, and the flow of the box is controlled and tracked by scanning the code.

In some embodiments of the invention, when the material is put into the material sealing box, the identification code of the material is scanned, and then the material is put into the box body; the system binds the material with the box body through the code scanning action, and then realizes the control and tracking of the material through the flow control and tracking of the material sealing box.

In some embodiments of the invention, when the waste is put into the waste sealing box, the identification code of the waste is scanned, and then the waste is put into the box body; the system binds the waste material with the box body through the code scanning action, and then realizes the control and tracking of the waste material through the flow control and tracking of the waste material sealing box.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

fig. 1 is a schematic structural diagram of a pharmaceutical production system according to an embodiment of the present invention;

fig. 2 is a schematic structural view of a pharmaceutical production system according to still another embodiment of the present invention;

FIG. 3 is a structural diagram of an electromagnetic attraction type aseptic sealed rapid transit valve according to an embodiment of the present invention, illustrating a state in which a sealing box is butted to a wall of a clean space unit;

FIG. 4 is a state diagram of the solenoid actuator aseptic sealed rapid transit valve of the present invention with the mobile valve sealingly locked to the main valve after the seal box is docked to the wall of the clean space unit;

FIG. 5 is a schematic diagram illustrating a state in which the electromagnetic attraction type aseptic sealed fast transfer valve is opened to communicate the first port with the second port after the sealing box is abutted to the wall of the clean space unit and the movable valve is sealed and locked with the main valve according to the embodiment of the present invention;

FIG. 6 is a schematic illustration of a process for producing material flow according to an embodiment of the present invention;

FIG. 7 is a schematic illustration of a production waste flow process according to one embodiment of the present invention;

FIG. 8 is a state transition diagram of a material containment vessel according to one embodiment of the present invention;

figure 9 is a state transition diagram of a waste seal box according to one embodiment of the present invention.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "at least one" means one, two, three, four, five, etc., and "a plurality" means at least two, e.g., two, three, four, five, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In one aspect of the invention, a pharmaceutical production system is provided. Referring to fig. 1, according to an embodiment of the present invention, the pharmaceutical production system includes: production ancillary zone 100, production zone 200, channel 300. Wherein, the production auxiliary area 100 comprises a liquid preparation room 110, a material storage room 120, a sealed box cleaning room 130 and a waste treatment room 140; the production area 200 includes at least one production plant 210; the passage 300 is provided between the production auxiliary area 100 and the production area 200 and separates the production auxiliary 100 area from the production area 200; the channel 300 is communicated with the production auxiliary area 100 and the production area 200 through a plurality of openable and closable channel interfaces 310, the channel 300 is provided with a material sealing box and a waste sealing box (not shown in the drawing) for logistics transportation between the production auxiliary area 100 and the production area 200, and the material sealing box and the waste sealing box are provided with sealing box interfaces matched with the channel interfaces 310; wherein, the production auxiliary area 100, the production area 200 and the channel 300 are at least of class C GMP cleanliness.

The pharmaceutical production system according to an embodiment of the present invention is further described in detail below.

Referring to fig. 1, according to some embodiments of the present invention, the channel interface for communicating the production shop with the channel includes a material interface 311 and a waste interface 312, the material interface 311 is used for interfacing with the material seal box, and the waste interface 312 is used for interfacing with the waste seal box. From this, material seal box and waste material seal box communicate through different interfaces and workshop to can further be favorable to guaranteeing that production material and production waste material can not take place cross contamination.

Referring to fig. 1, according to some embodiments of the present invention, the channel interface that communicates the pod cleaning bay with the channel includes a material interface 311 and a waste interface 312, the material interface 311 for interfacing with the material pod and the waste interface 312 for interfacing with the waste pod. Specifically, a material interface communicated with the cleaning room of the seal box and the channel is a material box cleaning interface, and a waste material interface communicated with the cleaning room of the seal box and the channel is a waste material box cleaning interface. From this, material seal box and waste material seal box communicate through different interface and seal box cleanness room to can further be favorable to guaranteeing that production material and production waste material can not take place cross contamination. In addition, it should be noted that the specific cleaning device provided in the seal box cleaning room is not particularly limited, and the seal box may be cleaned by a cleaning device commonly used in the art.

According to some embodiments of the present invention, a transfer room (not shown in the drawings) is provided in the production shop, and the channel interface is communicated with the transfer room. Thus, material from the production ancillary zone first enters the transfer room as a transfer. Furthermore, a public area and a private area can be divided in the transfer room so as to ensure that raw materials purchased by a certain user are stored in the private area. In combination with the flow control system, it is then possible to ensure that the raw materials used by themselves are used in the production process.

Referring to fig. 2, according to some embodiments of the present invention, the seal box cleaning room further includes a seal box storage room 150 between the seal box cleaning room and the passage, and the seal box storage room 150 communicates with the seal box cleaning room 130 through an openable and closable interface. Therefore, the cleaned sealing box can be temporarily stored in the sealing box storage room, and the material sealing box or the waste sealing box returns to a ready state.

Referring to FIG. 2, according to some embodiments of the present invention, the seal box storage compartment includes a material seal box storage compartment 150a and a waste seal box storage compartment 150b, and the waste seal box cleaning compartment 150b communicates with the waste treatment compartment 140 through an openable and closable interface. From this, deposit through spaced apart material seal box and deposit with the waste material seal box and deposit and respectively keep in material seal box and waste material seal box to can further be favorable to guaranteeing that production material and production waste material can not take place cross contamination. In addition, but between the waste material seal box is clean with the waste material handle through open closed interface intercommunication to discharge the production waste material to between the waste material is handled, then deposit the waste material seal box at the waste material seal box and temporarily store, with clean. In some embodiments of the invention, a waste treatment room is provided with sterilizing equipment such as a sterilizing cabinet to treat waste.

According to some embodiments of the invention, the channel comprises an upper channel and a lower channel (not shown in the figures), and the material seal and the waste seal are provided in the upper channel or the lower channel, respectively. Specifically, when adopting upper passageway transportation material seal box, adopt lower floor's passageway transportation waste material seal box, when adopting upper passageway transportation waste material seal box, adopt lower floor's passageway transportation material seal box. It can be understood that when the channel is designed by adopting an upper layer structure and a lower layer structure, the height of the channel interface communicated with the production auxiliary area and the production area is adaptively adjusted so as to meet the butt joint requirements of the material seal box and the waste seal box which are respectively positioned at the upper layer and the lower layer of the channel and the corresponding interfaces of the production auxiliary area and the production area.

According to some embodiments of the invention, the width of the channel is preferably set to (maximum material length x 3+ seal box width x 1.5). The length of the seal box is determined by the maximum material length, and the width of a channel occupied by the seal box when the seal box is in butt joint with the channel interface is about 1.5 times of the length of the material; in the worst case, when the left and right sides of the channel are respectively provided with the maximum box bodies for simultaneously butting and transferring materials, the high efficiency of the material cleaning channel can be ensured only by ensuring that the butted box bodies do not block the central channel, so that the maximum material length multiplied by 3 plus the width multiplied by 1.5 of the seal box can be used as the reference dimension for designing the channel width.

In addition, it should be noted that the specific types of the channel interface, the seal box interface, the material interface, the waste interface, and the like are not particularly limited as long as the interface has good sealing performance when being butted. For example, RTP valves, AB valves, etc. commonly used in the art may be used. If the logistics demand of the material of bigger size, can adopt the delivery window of bigger size as the interface. To further ensure the prevention of cross-contamination, the control system controls the doors on one side of all the transfer windows to be opened at most one door at a time.

More preferably, according to some embodiments of the present invention, the channel interface employs an electromagnetic attraction type sterile sealing rapid transit valve. Therefore, the use cost is low, and the interface docking is more flexible.

An electromagnetically attracted sterile sealing rapid transit valve 1000 according to an embodiment of the present invention will be described with reference to fig. 3 to 5. It should be noted that, in the description of the electromagnetic attraction type aseptic sealed rapid transit valve 1000, for simplicity and clarity of description, the "material seal box" and the "waste seal box" are summarized as the "seal box" for description; the description will be made with the term "production sub-area" and "production area" in general terms as "clean space unit".

As shown in fig. 3 to 5, the electromagnetic attraction type aseptic sealed rapid transit valve 1000 according to the embodiment of the present invention is used to perform aseptic butt joint between a sealed box and a clean space unit (the clean space unit may be an isolator, a clean room, etc.) to facilitate subsequent aseptic material transfer, wherein the clean space unit has a first interface a (see the references in fig. 4 and 5), which may be understood as a transfer interface for transferring aseptic materials into and out of the clean space unit.

The electromagnetic attraction type sterile sealing rapid transfer valve 1000 of the embodiment of the invention comprises a main valve component 1 and an auxiliary valve component 2.

Specifically, the main valve assembly 1 includes a rotatable main valve 10, an electromagnetic actuator 17, and an electrical contact 18. Wherein, the main valve 10 is rotatably installed on the inner sidewall of the wall body 19 of the first port a to open and close the clean space unit, and when the main valve 10 is in a closed state, the main valve 10 is in a sealing connection with the wall body 19; that is, the main valve 10 reliably seals the first port A of the clean space unit, which ensures that the sterile clean environment inside the clean space unit is not contaminated by the outside environment. The electric contact 18 is installed on the outer side wall of the wall body 19, so that when the seal box is in butt joint with the outer side wall of the wall body 19, the electric contact 18 is in contact with the seal box to enable a loop of the electronic control module to be conducted, and then the electronic control module controls corresponding functional components to act. The electrical contacts 18 may be semi-circular, cylindrical or other shapes, and may be selected according to the actual needs. An electromagnetic actuator 17 is installed on the main valve 10, and the electromagnetic actuator 17 is mainly used to generate a magnetic force, which includes an attractive force required during the coupling of the hermetic container to the clean space unit and a repulsive force required during the decoupling of the hermetic container from the isolation container.

The sub-valve assembly 2 includes a sub-valve 20 and a moving valve 21. Wherein the secondary valve 20 is fixed to the sealed box, the secondary valve 20 here can be understood as a part of a structure formed directly on the sealed box or as a separate component which is sealingly fixed to the sealed box; the secondary valve 20 has a second port B (see the references in fig. 4 and 5) communicating with the capsule, which can be understood as the transfer port of the sterile material in and out of the capsule. The moving valve 21 has a first position I and a second position II (see the labels in fig. 3), the first position I is located in the second port B, the second position II is located in the main valve 10, when the moving valve 21 is in the first position I, the moving valve 21 is located in the second port B and the moving valve 21 and the auxiliary valve 20 are tightly sealed, so as to ensure that the clean environment inside the sealed box is not polluted by the outside environment; when the movable valve 21 is at the second position II, the movable valve 21 is located in the main valve 10, and the movable valve 21 and the main valve 10 are locked and sealed, so that it can be ensured that contaminants in the space environment between the main valve 10 and the movable valve 21 (i.e. the middle space after butt-sealing) cannot enter the sealed box and the clean space unit, and the clean environment inside the sealed box and the clean space unit can be ensured without killing the space environment between the main valve 10 and the movable valve 21, and meanwhile, because the space environment between the main valve 10 and the movable valve 21 does not need to be killed, the butt-joint efficiency of the sealed box and the isolation is greatly improved, i.e. the aseptic sealing butt-joint speed is high.

The process of the aseptic butt joint of the sealing box and the clean space unit comprises the following steps: the main valve 10 is in the closed condition, the shifting valve 21 is in the first position I; when the auxiliary valve 20 is butted with the outer side wall of the wall body 19, the electric contact 18 is contacted with the auxiliary valve 20 to conduct a circuit of the electric control module, and the electric control module firstly controls the locking and sealing between the auxiliary valve 20 and the wall body 19; the electronic control module controls the release of the moving valve 21; the electric control module then controls the electromagnetic actuator 17 to attract the moving valve 21 to move from the first position I to the second position II, and when the moving valve 21 moves to the second position II, the electric control module controls the locking and sealing between the moving valve 21 and the main valve 10; the electric control module finally controls the main valve 10 to rotate from a closed state to an open state, so that the first interface A is communicated with the second interface B, and the quick sterile sealing butt joint of the sealing box and the clean space unit is realized, thereby facilitating the transfer of sterile materials.

The aseptic separation process of the sealing box and the clean space unit comprises the following steps: under the condition that the first interface A is communicated with the second interface B and the main valve 10 is in an opening state, when the seal box needs to be separated from the clean space unit, the electric control module firstly controls the main valve 10 to rotate from the opening state to a closing state, so that the first interface A is disconnected from the second interface B; the electric control module controls the moving valve 21 to be released from the main valve 10, and further controls the electromagnetic actuator 17 to generate a repulsive force to the moving valve 21, the repulsive force enables the moving valve 21 to move back to the first position I from the second position II, when the moving valve 21 returns to the first position I, the electric control module controls the moving valve 21 and the auxiliary valve 20 to be locked and sealed, and finally the electric control module controls the auxiliary valve 20 to be unlocked from the wall 19, and at the moment, the seal box can be separated from the wall 19. During the detachment of the sealed box from the clean space unit, the clean space unit and the sealed box are still in a sterile and clean environment. That is, the process of aseptically separating the sealed box and the clean space unit is exactly the reverse of the process of aseptically docking the sealed box and the clean space unit.

The electromagnetic attraction type sterile sealing rapid transfer valve 1000 provided by the embodiment of the invention has the following advantages: the first, simple structure achieves complex functions. The electromagnetic attraction type sterile sealing fast transfer valve 1000 in the embodiment of the invention mainly comprises a main valve component 1 and an auxiliary valve component 2, wherein the main valve component 1 comprises a main valve 10, an electromagnetic attraction device 17 and an electric contact 18, the auxiliary valve component 2 comprises an auxiliary valve 20 and a moving valve 21, and the whole structure is short; the butt joint process of the seal box and the clean space unit is as follows: firstly, the electric contact 18 is contacted with the seal box to lead a loop of the electric control module to be conducted, the electric control module sequentially controls the auxiliary valve 20 to be locked and sealed with the wall 19 of the clean space unit, the movable valve 21 and the auxiliary valve 20 are loosened, the electromagnetic suction device 17 sucks the movable valve 21 to move from the first position I to the second position II, the movable valve 21 is sealed and locked with the main valve 10 and the main valve 10 is opened, so that the first interface A and the second interface B are communicated, the sterile sealing of the seal box and the clean space unit is fast and efficiently butted, and sterilization and killing are not needed in the butting process; the process of disengaging the sealed box from the clean space unit is the reverse of the process of docking the sealed box to the clean space unit. Secondly, the interface shape and size have wide application range. The process of butting and separating the sealing box and the clean space unit is not required to be butted and separated by a rotary pressing sealing mode in the prior art, but an electric control module is adopted to control corresponding functional parts to act to realize locking and sealing of the locking mechanism, so that the interface can be in various shapes such as a circle, an ellipse, a square, a pentagon, a hexagon and the like, meanwhile, a common sealing ring is adopted to perform pressing sealing in a sealing principle, the requirement on the processing precision of the main valve 10 and the auxiliary valve 20 is not high, the size of the interface can be very large, the size of the interface can be much larger than that of the interface in the prior art, the length and the width (diameter) of the interface are 1000mm, and the application and popularization are facilitated. And thirdly, complete electric control is realized, and the requirements of providing high-pressure air and the like for the surrounding environment are not required. Fourthly, the reliability of aseptic sealing is ensured by combining the whole process. The locking and sealing device is characterized in that the locking and sealing device comprises a locking and sealing device, a locking and sealing device and a sealing device, wherein the locking and sealing device comprises a locking and sealing device, a locking and sealing device and a sealing device.

As shown in fig. 3 and 4, according to one embodiment of the present invention, the main valve 10 comprises a main valve body 101 and a first butt end 102, the first butt end 102 being located on a side of the main valve body 101 and defining a cavity 1021 together with the main valve body 101; the sub-valve 20 comprises a second butt end 201 and a third butt end 202 which are connected with each other, the second butt end 201 is used for butt joint with the outer side wall of the wall body 19, and the third butt end 202 is used for butt joint with the first butt end 102; when the second abutting end 201 abuts against the outer side wall of the wall 19, the third abutting end 202 abuts against the first abutting end 102 and is located in the first interface a, so that the cavity 1021 is connected with the second interface B, and the inner peripheral wall of the cavity 1021 is flush with the inner peripheral wall of the second interface B; the second position II of the moving valve 21 is located in the cavity 1021, which ensures that the moving valve 21 moves smoothly between the first position I and the second position II.

Specifically, the first abutting end 102 protrudes from one side of the main valve body 101, and the third abutting end 202 also protrudes from one side of the auxiliary valve 20, so that the first abutting end 102 on the main valve body 101 is abutted with the third abutting end 202 of the auxiliary valve 20, and the inner peripheral wall of the cavity 1021 is flush with the inner peripheral wall of the second interface B, which can ensure that the movable valve 21 can move smoothly between the first position I and the second position II; it should be noted that the width of the peripheral surface of the moving valve 21 is greater than the gap between the first abutting end 102 and the third abutting end 202 when the first abutting end 102 and the third abutting end 202 are in the abutting state, so that the moving valve 21 can be ensured to move more smoothly between the first position I and the second position II, and the moving valve 21 is prevented from being stuck in the gap between the first abutting end 102 and the third abutting end 202 when the first abutting end 102 and the third abutting end 202 are in the abutting state.

As shown in fig. 3, according to a further embodiment of the present invention, the electromagnetic actuator 17 is mounted on the main valve body 101 at the concave bottom of the cavity 1021. Therefore, the electromagnetic actuator 17 can be better ensured to move the movable valve 21 between the first position I and the second position II, and the arrangement position of the electromagnetic actuator 17 is more reasonable.

As shown in fig. 3, according to a further embodiment of the present invention, the main valve assembly 1 further includes a first sealing ring 11, the first sealing ring 11 being mounted on an inner circumferential wall of the first port a; when the main valve 10 is in the closed state, the end surface of the first butt end 102 of the main valve 10 is in sealing connection with the first seal ring 11. By providing the first packing 11 on the inner circumferential wall of the first port a, it is possible to prevent bacteria outside from entering the clean space unit and the seal box during the docking of the seal box and the isolation box.

As shown in fig. 3, according to a still further embodiment of the present invention, the main valve assembly 1 further includes a second sealing ring 12, the second sealing ring 12 being mounted on an inner side wall of the wall 19; when the main valve 10 is in the closed state, the main valve 10 is also in sealing connection with the second sealing ring 12, which more reliably ensures that the interior clean environment of the clean space unit is not contaminated by the outside environment.

As shown in fig. 3, according to a further embodiment of the present invention, the main valve assembly 1 further includes a third sealing ring 13, the third sealing ring 13 being mounted on the inner peripheral wall of the cavity 1021; when the shifting valve 21 is shifted to the second position II and locked, the shifting valve 21 is sealingly connected with the third sealing ring 13. That is, the moving valve 21 is locked on the inner peripheral wall of the cavity 1021, and the third sealing ring 13 is pressed by the locking mode, so that the sealing connection between the moving valve 21 and the third sealing ring 13 is ensured, and therefore, the contamination in the space environment (i.e. the middle space after butt-sealing) between the main valve 10 and the moving valve 21 can be ensured not to enter the sealing box and the clean space unit, and the inside clean environment of the sealing box and the inside clean environment of the clean space unit can be ensured without killing the space environment between the main valve 10 and the moving valve 21, and meanwhile, because the space environment between the main valve 10 and the moving valve 21 is not required to be killed, the butt-joint efficiency of the sealing box and the clean space unit is greatly improved, i.e. the aseptic sealing butt-joint speed is fast.

As shown in fig. 3 and 4, according to a further embodiment of the present invention, the sealing interface between the moving valve 21 and the third sealing ring 13 is a slope, which can make the structure simpler and the sealing effect better.

As shown in fig. 3, 4 and 5, there are two alternative ways of locking the displacement valve 21 to the inner peripheral wall of the cavity 1021 of the main valve 10 according to some embodiments of the invention. Wherein, one locking mode is as follows: a first locking mechanism (here, the first locking mechanism is not shown, and may be similar in structure to a third locking mechanism 25 hereinafter, and may be referred to as the third locking mechanism 25 hereinafter) is provided between the moving valve 21 and the inner peripheral wall of the cavity 1021 of the main valve 10, and includes a first locking hook mounted on the inner peripheral wall of the cavity 1021 and a second locking hook formed on the moving valve 21; when the moving valve 21 is located at the second position II, the electronic control module controls the first locking hook to hook the second locking hook, so as to lock the moving valve 21, so that the moving valve 21 is hermetically connected with the third sealing ring 13; when the moving valve 21 needs to move to the first position I, the electronic control module controls the first locking hook to extend out, so that the first locking hook and the second locking hook are released. It can be understood that the first locking mechanism does not need to be continuously powered, the locking effect is good, and the moving valve 21 can be effectively ensured to be in sealed connection with the third sealing ring 13, but the first locking mechanism is slightly complex in structure.

The other locking mode is as follows: the locking between the mobile valve 21 and the inner peripheral wall of the cavity 1021 of the main valve 10 is performed as follows: the moving valve 21 moves to the second position II and is locked by the suction force of the electromagnetic actuator 17 and maintains the locked state, so that the moving valve 21 is hermetically connected with the third sealing ring 13. It can be understood that the magnetic locking mode enables the structure to be simpler and the practicability to be higher.

As shown in fig. 3 and 4, according to a further embodiment of the present invention, the main valve assembly 1 further includes one or more position detection modules 15, and the position detection modules 15 are configured to detect whether the moving valve 21 reaches the first position I to ensure a locking seal between the moving valve 21 and the sub-valve 20, and detect whether the moving valve 21 reaches the second position II to ensure a locking seal between the moving valve 21 and the inner peripheral wall of the cavity 1021. That is, the position detection module 15 is provided to detect whether the movable valve 21 precisely reaches a corresponding specific position, so that the movable valve 21 is locked and sealed with the sub-valve 20 or the main valve 10, respectively, and the reliability of the locking and sealing is ensured.

As shown in fig. 3, 4 and 5, according to a still further embodiment of the present invention, the position detecting module 15 includes a spring 151 and a position contact sensor 152, one end of the spring 151 is connected to the main valve body 101 and located at the concave bottom of the concave cavity 1021, the other end of the spring 151 is connected to the position contact sensor 152, and the position contact sensor 152 is connected to the moving valve 21. Thus, when the moving valve 21 moves from the first position I to the second position II, the spring 151 is gradually compressed, the position contact sensor 152 accurately senses whether the moving valve 21 reaches the second position II, and when the spring 151 is compressed to a specific position, the position contact sensor 152 senses that the moving valve 21 has reached the second position II, the moving valve 21 and the inner peripheral wall of the cavity 1021 need to be locked to realize the sealing between the moving valve 21 and the inner peripheral wall of the cavity 1021, for example, the locking sealing between the moving valve 21 and the inner peripheral wall of the cavity 1021 is realized by the sealing connection between the moving valve 21 and the third sealing ring 13; when the moving valve 21 moves from the second position II to the first position I, the spring 151 is gradually pulled up, the position contact sensor 152 accurately senses whether the moving valve 21 reaches the first position I, and when the spring 151 is compressed to a specific position, the position contact sensor 152 senses that the moving valve 21 has reached the first position I, and the moving valve 21 and the inner peripheral wall of the second port B need to be locked to realize the sealing between the moving valve 21 and the inner peripheral wall of the second port B, for example, the locking sealing between the moving valve 21 and the inner peripheral wall of the second port B is realized by the sealing connection of the moving valve 21 and the fifth sealing ring 23.

It should be noted that the number of the position detection modules 15 may be appropriately arranged according to the size of the moving valve 21, and is at least three, so that it is ensured that the exact state of the moving valve 21 is obtained.

As shown in fig. 3, 4 and 5, according to a further embodiment of the present invention, the main valve assembly 1 further includes a rotating shaft 16, the rotating shaft 16 is installed on an inner sidewall of the wall 19, and the main valve 10 is installed on the rotating shaft 16. It will be appreciated that the main valve 10 may be conveniently rotated with respect to the clean space unit by providing the rotating shaft 16 so that the main valve 10 can close and open the clean space unit.

As shown in fig. 3, 4 and 5, according to a further embodiment of the present invention, the sub-valve assembly 2 further includes a fourth sealing ring 22, the fourth sealing ring 22 being mounted on the peripheral wall of the first port a; when the second butt joint end 201 is butted with the outer side wall of the wall 19, the end surface of the third butt joint end 202 is connected with the fourth sealing ring 22 in a sealing manner; therefore, the cleanliness of the space environment in the sealing box can be ensured.

As shown in fig. 3 and 4, according to still further embodiments of the present invention, the sub-valve assembly 2 further includes a second latch mechanism 24, the second latch mechanism 24 includes a third latch hook 241 and a fourth latch hook 242, the third latch hook 241 is mounted on an outer sidewall of the wall body 19, and the fourth latch hook 242 is formed on the second abutting end 201; when the second butt joint end 201 is butted on the outer side wall of the wall 19, the electronic control module controls the third locking hook 241 to hook the fourth locking hook 242 tightly so as to lock the secondary valve 20, so that the end surface of the third butt joint end 202 is connected with the fourth sealing ring 22 in a sealing manner; when the sealing box is not required to be docked with the clean space unit, the electronic control module controls the third locking hook 241 to extend, so that the third locking hook 241 is released from the fourth locking hook 242. It can be understood that, by providing the second locking mechanism 24, the main purpose is to lock the sub-valve 20 and the wall 19 by the second locking mechanism 24 when the second abutting end 201 abuts against the outer side wall of the wall 19, so that the end surface of the third abutting end 202 presses the fourth sealing ring 22, the sealing between the sub-valve 20 and the wall 19 is realized, and the reliability of the sealing is ensured.

As shown in fig. 4, according to a further embodiment of the present invention, the sub-valve assembly 2 includes a fifth packing 23, the fifth packing 23 being mounted on an inner peripheral wall of the second port B; when the shifting valve 21 is shifted to the first position I and locked, the shifting valve 21 is sealingly connected with the fifth sealing ring 23. That is, the moving valve 21 is locked on the inner peripheral wall of the second port B, and the fifth sealing ring 23 is pressed by the locking manner, so as to ensure the sealing connection between the moving valve 21 and the fifth sealing ring 23, thereby ensuring that the contaminants in the space environment (i.e. the middle space after butt-joint sealing) between the main valve 10 and the moving valve 21 do not enter the sealed box and the clean space unit, and ensuring the clean environment inside the sealed box and the clean space unit without sterilizing the space environment between the main valve 10 and the moving valve 21, and simultaneously, greatly improving the butt-joint efficiency between the sealed box and the clean space unit because the space environment between the main valve 10 and the moving valve 21 does not need to be sterilized.

As shown in fig. 3, according to a further embodiment of the present invention, the sealing interface between the moving valve 21 and the fifth sealing ring 23 is a slope, which can make the structure simpler and the sealing effect better.

As shown in fig. 3, according to some embodiments of the present invention, the sub-valve assembly 2 further includes a third latch mechanism 25, the third latch mechanism 25 including a fifth latch hook 251 and a sixth latch hook 252, the fifth latch hook 251 being mounted on an inner circumferential wall of the second port B, the sixth latch hook 252 being formed on the moving valve 21; when the shifting valve 21 is located at the first position I, the electronic control module controls the fifth locking hook 251 to hook the sixth locking hook 252 tightly so as to lock the shifting valve 21, so that the shifting valve 21 is connected with the fifth sealing ring 23 in a sealing manner; when the moving valve 21 needs to move to the second position II, the electronic control module controls the fifth locking hook 251 to extend, so that the fifth locking hook 251 and the sixth locking hook 252 are released. It can be understood that the third locking mechanism 25 has a good locking effect, and can effectively ensure that the moving valve 21 is in sealing connection with the third sealing ring 13.

According to a further embodiment of the present invention, the sub-valve assembly 2 further includes a sixth sealing ring 26, the sixth sealing ring 26 being provided on the outer peripheral wall of the moving valve 21; the sixth sealing ring 26 seals the inner peripheral wall of the cavity 1021 or the inner peripheral wall of the first port a, where the outer peripheral wall of the transfer valve 21 is directly opposite to the outer peripheral wall of the transfer valve 21, when the transfer valve 21 is moved between the first position I and the second position II. By providing the sixth seal ring 26 in this way, the space between the transfer valve 21 and the main valve 10 (i.e., the intermediate space after butt sealing) can be always sealed during the movement of the transfer valve 21 between the first position I and the second position II, and contaminants in the environment of the space between the transfer valve 21 and the main valve 10 can be prevented from entering the seal box.

The electromagnetic attraction type aseptic sealed rapid transit valve 1000 according to an embodiment of the present invention will be described as a specific example.

In this particular example, the electromagnetic attraction type aseptic sealed rapid transfer valve 1000 is used to aseptically interface a sealed box with a clean space unit for subsequent aseptic material transfer, where the clean space unit has a first interface A, which may be understood as a transfer interface for the aseptic material to and from the clean space unit.

In this specific example, the electromagnetic attraction type aseptic sealed rapid transfer valve 1000 mainly includes a main valve assembly 1 and an auxiliary valve assembly 2.

Specifically, the main valve assembly 1 includes a main valve 10, a solenoid actuator 17, an electric contact 18, a first seal ring 11, a second seal ring 12, a third seal ring 13, a spring 151, and a position contact sensor 152.

Wherein, the main valve 10 is rotatably installed on the inner sidewall of the wall body 19 of the first port a to open and close the clean space unit, and when the main valve 10 is in a closed state, the main valve 10 is in a sealing connection with the wall body 19; the main valve 10 includes a main valve body 101 and a first interface end 102, the first interface end 102 being located on a side of the main valve body 101 and defining a cavity 1021 with the main valve body 101. The electromagnetic actuator 17 is mounted on the main valve body 101 at the concave bottom of the cavity 1021. The electrical contacts 18 are mounted on the outside wall of the wall 19. The first sealing ring 11 is arranged on the inner peripheral wall of the first port A; when the main valve 10 is in the closed state, the end surface of the first butt end 102 of the main valve 10 is in sealing connection with the first seal ring 11. The second sealing ring 12 is arranged on the inner side wall of the wall body 19; the main valve 10 is also in sealing connection with the second sealing ring 12 when the main valve 10 is in the closed state. A third packing 13 is installed on an inner circumferential wall of the cavity 1021. One end of the spring 151 is connected to the main valve body 101 and positioned at the concave bottom of the cavity 1021, the other end of the spring 151 is connected to a position contact sensor 152, and the position contact sensor 152 is connected to the moving valve 21. The fourth sealing ring 22 is installed on the inner peripheral wall of the first port a; when the second abutting end 201 abuts against the outer side wall of the wall 19, the end surface of the third abutting end 202 is connected with the fourth sealing ring 22 in a sealing manner.

The sub-valve assembly 2 includes a sub-valve 20, a moving valve 21, a fourth sealing ring 22, a third latching hook 241, a fourth latching hook 242, a fifth sealing ring 23, a fifth latching hook 251, a sixth latching hook 252, and a sixth sealing ring 26.

Wherein, the auxiliary valve 20 is fixed on the sealed box, the auxiliary valve 20 has the second interface B communicated with sealed box; the second interface B may be understood as a transfer interface for the sterile material to and from the sealed box. The sub-valve 20 comprises a second butt end 201 and a third butt end 202 which are connected with each other, the second butt end 201 is used for butt joint with the outer side wall of the wall body 19, and the third butt end 202 is used for butt joint with the first butt end 102; when the second docking end 201 is docked with the outer sidewall of the wall 19, the third docking end 202 is docked with the first docking end 102 and is located in the first interface a. The fourth sealing ring 22 is installed on the inner peripheral wall of the first port a; the third latch hook 241 is installed on the outer sidewall of the wall 19, and the fourth latch hook 242 is formed on the second abutting end 201; the fourth packing 22 is mounted on the inner peripheral wall of the first port a. When the second abutting end 201 abuts against the outer side wall of the wall 19, the electrical contact 18 contacts with the auxiliary valve 20 to conduct a loop of the electronic control module, the electronic control module controls the third locking hook 241 to be locked with the fourth locking hook 242, and the third abutting end 202 presses the fourth sealing ring 22 under the condition that the third locking hook 241 and the fourth locking hook 242 are locked, so that the third abutting end 202 is connected with the fourth sealing ring 22 in a sealing manner, that is, the third abutting end 202 is connected with the wall 19 in a sealing manner. The shifting valve 21 has a first position I in the second port B and a second position II in the cavity 1021 of the main valve 10. The fifth sealing ring 23 is installed on the inner peripheral wall of the second port B; the fifth locking hook 251 is installed on the inner circumferential wall of the second mouthpiece B, and the sixth locking hook 252 is formed on the moving valve 21. When the moving valve 21 is in the first position I, the moving valve 21 is located in the second port B and the moving valve 21 and the sub-valve 20 are locked by the fifth locking hook 251 and the sixth locking hook 252, so that the moving valve 21 presses the fifth sealing ring 23, thereby achieving the locking seal between the moving valve 21 and the sub-valve 20. When the moving valve 21 needs to move from the first position I to the second position II, the fifth locking hook 251 may be extended under the control of the electronic control module, so that the fifth locking hook 251 is unlocked from the sixth locking hook 252, thereby facilitating the movement of the moving valve 21. A sixth seal ring 26 is provided on the outer peripheral wall of the transfer valve 21; the sixth sealing ring 26 seals the inner peripheral wall of the cavity 1021 or the inner peripheral wall of the first port a, where the outer peripheral wall of the transfer valve 21 is directly opposite to the outer peripheral wall of the transfer valve 21, when the transfer valve 21 is moved between the first position I and the second position II.

The process of the aseptic butt joint of the sealing box and the clean space unit comprises the following steps: the main valve 10 is in a closed state, the main valve 10 and the wall 19 are sealed with the wall 19 through the first sealing ring 11 and the second sealing ring 12, the shifting valve 21 is in the first position I, and the shifting valve 21 is locked with the sixth locking hook 252 through the fifth locking hook 251 so as to enable the shifting valve 21 to be in sealing connection with the fifth sealing ring 23, so that the shifting valve 21 is in sealing connection with the secondary valve 20; it should be noted that, at this time, the inner peripheral wall of the second interface B is flush with the inner peripheral wall of the cavity 1021 of the main valve 10; when the auxiliary valve 20 is butted with the outer side wall of the wall 19, the electric contact 18 is contacted with the auxiliary valve 20 to conduct a circuit of the electric control module, the electric control module firstly controls the third latch hook 241 to latch the fourth latch hook 242, and when the third latch hook 241 and the fourth latch hook 242 are latched, the second butted end 201 of the auxiliary valve 20 is butted against the fourth sealing ring 22 to enable the second end to be connected with the fourth sealing ring 22 in a sealing manner, so that the latching sealing between the second butted end 201 and the wall 19 is realized; the electronic control module controls the fifth locking hook 251 to extend out, so that the fifth locking hook 251 and the sixth locking hook 252 are released, at this time, the electronic control module controls the electromagnetic actuator 17 to generate a magnetic force (the magnetic force at this time is an attractive force), so that the movable valve 21 moves from the first position I to the second position II, when the spring 151 is compressed to a specific position, the position contact sensor 152 detects that the movable valve 21 has tightly reached the second position II, at this time, the electronic control module controls the electromagnetic actuator 17 to continuously generate the magnetic force, so as to fix the movable valve 21 at the second position II in a magnetic attraction locking manner, and meanwhile, the movable valve 21 presses the third sealing ring 13 at the second position II, so that the movable valve 21 is in sealing connection with the third sealing ring 13, thereby achieving the locking sealing of the movable valve 21 and the inner peripheral wall of the cavity 1021 of the main valve 10; the electric control valve controls the main valve 10 to rotate from a closed state to an open state, so that the first interface A and the second interface B are communicated, and sterile materials in the sealed box can conveniently enter the clean space unit from the first interface A and the second interface B.

It should be noted that in this example, the process of sterile detachment of the enclosure from the clean space unit is exactly the reverse of the process of sterile docking of the enclosure to the isolation zone.

The electromagnetic attraction type aseptic sealed rapid transfer valve 1000 of this specific example has the following advantages: first, the whole structure is simpler, has realized the sealed box and has had the complicated function of the quick butt joint of clean space unit aseptic seal through simple structure. Secondly, the shape and size of the interface (the interface refers to the first interface A and the second interface B) are applicable to a wide range. Because the butt joint and the separation of the seal box and the clean space unit are realized without depending on a rotary compression sealing mode in the prior art, but the electric control module is adopted to control the corresponding functional parts to act to realize the locking and sealing of the locking mechanism, the shape of the interface can be circular, oval, square, pentagonal, hexagonal and other shapes, meanwhile, the common sealing ring is adopted to carry out compression sealing on the sealing principle, the requirement on the processing precision of the main valve 10 and the auxiliary valve 20 is not high, the size of the interface can be greatly increased, the size of the interface can be much larger than that of the interface in the prior art, the length and the width (diameter) are 1000mm, and the application and the popularization are facilitated. And thirdly, complete electric control is realized, and the requirements of providing high-pressure air and the like for the surrounding environment are not required. Fourthly, the reliability of aseptic sealing is ensured by combining the whole process. The locking and sealing device is characterized in that the locking and sealing device comprises a locking and sealing device, a locking and sealing device and a sealing device, wherein the locking and sealing device comprises a locking and sealing device, a locking and sealing device and a sealing device.

In this specific example, the functions of the functional components are the same as those described above, and are not described in detail here.

In addition, the specific transportation manner of the material seal box and the waste seal box in the middle passage is not particularly limited, and for example, a manual transport vehicle, an Automatic Guided Vehicle (AGV), or the like may be used.

According to some embodiments of the invention, besides physical isolation between the production workshops, the auxiliary systems such as air conditioning and disinfection are also independent of each other, so that cross contamination between the production workshops can be further avoided.

According to some embodiments of the present invention, the production equipment used in each production plant is preferably disposable equipment (e.g., plastic equipment, etc.). Therefore, the cost of producing multiple batches of products can be further reduced.

According to some embodiments of the present invention, the material seal box and the waste seal box are respectively marked with different colors, and are never mixed, so as to avoid possible cross contamination.

According to some embodiments of the present invention, the pharmaceutical production system of the present invention may further comprise: raw material warehouse, inspection laboratory and finished product warehouse (not shown in the drawings). Specifically, the raw material warehouse is divided into a public area and a private area so as to manage and track the attribution, the validity period, the storage environment and the like of the raw materials and ensure the effectiveness of the storage and transportation of the raw materials. To accomplish this, according to some embodiments of the present invention, the raw materials may be inspected and repackaged before entering the plant. The detection laboratory is suitable for detecting the samples to be detected in each production workshop and can be shared by a plurality of workshops. The finished product warehouse is suitable for receiving finished products of various production workshops and carrying out operations such as filling, inspection, releasing and the like.

butting a material seal box containing production materials with a channel interface of a production workshop in a production area, and providing the production materials for the production workshop; then, the material seal box discharging the production materials is butted with a channel interface between seal box cleaning in the production auxiliary area, and the material seal box is cleaned;

butting the waste material sealing box with a channel interface of a production workshop in a production area, and providing production waste materials into the waste material sealing box;

butting a waste material sealing box filled with production waste materials with a channel interface of a waste material treatment room in the production auxiliary area, and discharging the production waste materials to the waste material treatment room; then the waste material seal box discharging the production waste material is butted with a channel interface between the seal box cleaning rooms in the production auxiliary area, and the waste material seal box is cleaned.

Specifically, the flow process of the production material and the production waste is shown in fig. 6 and 7, respectively.

In addition, in some embodiments of the present invention, each production shop also involves an operation of sending the sample to be tested to a testing laboratory and sending the finished product to a finished product warehouse, which can also be implemented by the logistics method of the present invention. It will be appreciated that the seal boxes used for the transport of the samples and products to be tested are independent of the material and fertilizer seal boxes described above to avoid cross contamination. More specifically, for the sample to be detected, the sample can be firstly transported to a transfer chamber in front of a detection laboratory; for finished products, the finished products can be transported to a transfer room before a finished product warehouse, and then filling, inspection, release and the like are carried out.

The pharmaceutical manufacturing method according to an embodiment of the present invention is further described in detail below.

According to some embodiments of the invention, after the sterilization and cleaning process, the material or waste containment boxes are transferred to a containment box holding room for temporary storage.

According to some embodiments of the invention, the pharmaceutical production method further comprises: according to the body of the material seal box or the waste seal box and the content of the body, the material seal box or the waste seal box is coded so as to carry out state control and tracking on the material seal box or the waste seal box and carry out information control and tracking on the transported content. Therefore, before each channel interface is in butt joint with the seal box interface, the codes of the material seal box or the waste seal box can be recognized firstly, and correctness check is carried out, so that the channel interfaces are prevented from being in butt joint with the seal box interface mistakenly to cause pollution.

According to some embodiments of the invention, the material or waste containment is externally affixed with a uniquely identified identification code, and the flow of the enclosure is controlled and tracked by scanning the code.

According to some embodiments of the invention, when the material is put into the material sealing box, the identification code of the material is scanned, and then the material is put into the box body; the system binds the material with the box body through the code scanning action, and then realizes the control and tracking of the material through the flow control and tracking of the material sealing box.

According to some embodiments of the invention, when waste is put into the waste sealing box, the identification code of the waste is scanned, and then the waste is put into the box body; the system binds the waste material with the box body through the code scanning action, and then realizes the control and tracking of the waste material through the flow control and tracking of the waste material sealing box.

For ease of understanding, the method of information control and tracking by encoding the seal box is described in further detail below with reference to fig. 8 and 9.

First, each seal box includes its own box code and its contents material code. In order to distinguish the kind of the seal box, the IDs of the material seal box and the waste seal box are distinguished. For example, the material seal ID starts with W and the waste seal ID starts with F. For the contents of the material seal box, the original material ID may begin with Y, the home-made material ID may begin with Z, and the other material IDs may begin with Q. Wherein, the original material generally refers to the purchased material with an external package, and can be directly sent to a production workshop without secondary processing, and the self-made material generally refers to the material prepared according to the production requirement (such as the liquid material prepared in the liquid preparation room). Thus, each material or waste containment vessel is provided with a code containing information about both the ID of the vessel itself and its contents ID.

In some embodiments, only necessary information may be provided for the original material that the user needs to keep secret, such as: the material bar code, the validity period, the storage condition and the like, and the logistics code can be adopted in the whole process of the factory logistics system to finish the transportation process of the material to the production workshop.

Further, when the material code is generated, the specific production task and the specific workshop number are included, so that the comparison and confirmation during the transportation are convenient. Meanwhile, the material code can also comprise information such as an operator, the exact composition of the material, a quality inspector and the like when the material code is generated, so that the material can be managed and traced.

According to some embodiments of the invention, the box body coding and the material coding can be realized through the two-dimensional code, and the generated two-dimensional code can be pasted outside the material outer package after being printed.

Further, when the materials need to be transported, the staff in the liquid distribution room/the material storage room can send a transportation request to the system, wherein the transportation request can comprise information such as material types, numbers of the going workshops and numbers of the affiliated tasks.

Furthermore, after the manual transport vehicle/AGV in the channel receives the transport request, a material seal box is taken out from the seal box storage position, the ID of the material seal box is obtained, the system automatically binds the ID of the material seal box with the detailed information of the material transport request and stores the detailed information into a related database table, and the database table can be used for maintaining all current transport tasks.

Specifically, the manual transport vehicle/AGV transports the material seal box to go and join in marriage between liquid/material and deposit and get the material between, join in marriage the in-process that the staff between liquid/material was deposited and place the material to the seal box, every time put the code of a material, the system compares whether this material code is unanimous with the task number/the workshop number of the transportation task that the seal box corresponds this moment, the inconsistency just gives no permission to the scanning terminal sends out the warning and takes notes this time unusual. When a material is successfully put into the box, the system database adds a material code to the material list structure corresponding to the ID of the sealed box. In addition, in some embodiments, an auxiliary camera can be further arranged above the interface, abnormal operations such as putting materials without scanning and giving an alarm and still putting the materials are automatically monitored through an AI technology, if the abnormal operations occur, the sealed box is judged to be possibly polluted, then the sealed box is correspondingly refused to be opened when the sealed box is tried to be butted with a production workshop, and meanwhile, the system prompts the content of the sealed box to be treated as waste materials.

Further, the manual transport vehicle/AGV transports the seal box to a preset production workshop and is in butt joint, if the wrong production workshop is in butt joint, the system refuses to open the seal valve and sends out warning information; at this time, the seal box is allowed to be docked again in the correct production workshop; after the seal box is in butt joint with a correct production workshop and the seal valve is opened, when people in the production workshop take out materials, each material is taken out and code-scanned once, if the materials are inconsistent with the serial number of the workshop, an alarm is given out, and the materials are required to be left in the seal box. In addition, an auxiliary camera can be arranged above an interface between the seal box and the production workshop, whether the situation that the materials are taken out but not scanned is automatically monitored through an AI technology, or the abnormal behavior that the materials are taken out even if an alarm is given out, and if the abnormal behavior occurs, the system gives an alarm and records.

On the other hand, the processes of encoding and controlling management of production waste discharge in a production workshop are similar by using a waste seal box, and the difference is that after the waste seal box is transported by a manual transport vehicle/AGV and is butted with the production workshop, a worker loads the production waste into the waste seal box and transports the production waste to a waste treatment room by the manual transport vehicle/AGV, wherein specific management methods such as monitoring, alarming and the like are not repeated.

Further, each time the material and waste containment are transported, the containment cleaning room must be docked for cleaning and recording. The sealed box returns to the storage place after being cleaned and is scanned, the sealed box returns to the initial ready state, and one transportation process is finished.

In summary, in the method for controlling and tracking information by encoding the seal box, the destination information of the material is bound at the material code generation stage; in addition, the ID dynamic binding list substructure of the box body comprises a plurality of material information, and when the substructure is expanded (namely when the materials are loaded), the destination of the materials is compared with that of the box to determine whether the materials are consistent with the destination of the box, so that when the materials are really transported, the correctness of material transportation can be controlled only by comparing the destination information corresponding to the ID of the box body. Thus, the capsule can transport a plurality of materials at a time, but the materials must be destined for the same plant, consistent with the capsule having to be cleaned for a single transport.

In addition, it should be noted that all the features and advantages described above for the pharmaceutical production system are also applicable to the pharmaceutical production method, and are not described in detail herein.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.

Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.

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