A method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry

Abstract

The present invention relates to a method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry. The method includes: a server integrated with a Direct system is communicatively connected to PLC devices of upstream and downstream devices in the pharmaceutical industry. The method includes: the Direct system receives an operation instruction from a user, constructs a main program operation process of the PLC devices by means of a configurable configuration tool, and constructs a subprogram for each main program by means of the configurable configuration tool and parameter attribute information according to the actual requirements of process configuration and the parameter information of the device to which the PLC device corresponding to the current main program belongs; when receiving a start instruction triggered by the user, each device to which the PLC devices belonging to the main program operation process belong executes each process. The above method realizes flexible configuration, ensuring coordinated linkage of upstream and downstream devices of the production line without affecting production, without the need to stop production, and without the need to modify the device program.

Description

Technical Field

[0001] The present invention relates to computer software technology, and in particular to a method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry. Background Art

[0002] The prior art discloses a development method of a PLC graphical editor based on XML technology. This method performs PLC graphical editing based on XML technology, configures functions and related attributes of the function module connection diagram using the extensibility feature of XML files, performs corresponding attribute configuration according to different program block types, generates a function module connection diagram by reading the content of XML files, realizes the automatic wiring function of program blocks, facilitates user operation, and can modify the function module connection diagram by only modifying the content of XML files. Finally, the information of each PLC program block used can be parsed and sent to the lower computer for processing, providing great convenience for the PLC graphical editing of technicians.

[0003] The above method can be conveniently edited by a third party or remotely, and it protects the generality of the programming method; however, corresponding XML parsing modules still need to be defined for PLCs of different manufacturers. After users perform graphical programming through XML technology, they create or modify PLC programs through the XML parsing module and run the modified program logic in the PLC; ultimately, the program is still modified and run on the PLC. The above method is not applicable to the pharmaceutical industry because, due to the particularity of the pharmaceutical industry, the PLCs of manufacturers cannot be modified.

[0004] Therefore, how to achieve automatic control of the PLC programs of multiple upstream and downstream manufacturers without modifying the PLC programs of manufacturers has become an urgent technical problem at present. Summary of the Invention

[0005] (1) Technical Problems to be Solved

[0006] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry.

[0007] (2) Technical Solutions

[0008] To achieve the above object, the main technical solutions adopted by the present invention include:

[0009] In a first aspect, an embodiment of the present invention provides a method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry. A server integrated with a Direct system is communicatively connected to PLC devices of upstream and downstream devices in the pharmaceutical industry. Each PLC device in the upstream and downstream devices is independent of each other. The method includes:

[0010] The editing interface of the Direct system receives the operation instructions of the user and constructs the main program operation processes of the PLC devices of the upstream device and the downstream device with the help of configurable configuration tools.

[0011] For each main program in each main program operation process, according to the actual requirements of the process configuration and the parameter information of the device to which the PLC device corresponding to the current main program belongs, with the help of configurable configuration tools and parameter information, each subprogram of each main program is constructed, and each operation step in the subprogram is a standardized step that meets the SOP operation regulations and has executable assignment information.

[0012] When receiving the start instruction triggered by the user, each process is executed based on the devices to which the PLC devices in the main program operation process belong.

[0013] Optionally, the method further includes:

[0014] The Direct system generates and stores the electronic batch record data of each PLC device during the execution of the process.

[0015] Optionally, when the server integrated with the Direct system is communicatively connected to the MES system in the pharmaceutical industry, the method further includes:

[0016] The MES system reads each formulation parameter and assignment information in the subprogram of each main program, and generates and stores the electronic batch record data of each PLC device during the execution of the process.

[0017] Optionally, when receiving the start instruction triggered by the user, executing each process based on the devices to which the PLC devices in the main program operation process belong includes:

[0018] The Direct system encapsulates the configured main program operation process and the subprogram processes of each main program to form a production instruction sheet. The MES system calls the production instruction sheet (inputting products and production quantities) to issue process instructions to the devices to which each PLC device belongs based on the encapsulated program to execute each process.

[0019] Optionally, when receiving the start instruction triggered by the user, executing each process based on the devices to which the PLC devices in the main program operation process belong includes:

[0020] After the main program operation process and the subprogram processes of each main program are configured, the Direct system checks whether they meet the SOP operation regulations. If so, an operation button for starting is displayed on the main interface.

[0021] After the user triggers the operation button to send a start instruction, the Direct system sends operation instructions to the devices to which the corresponding PLC devices belong through the OPC method according to the information of each process, so that the devices to which each PLC device belongs execute each process.

[0022] Optionally, the method further includes:

[0023] The main interface of the Direct system displays the execution process information of the current process.

[0024] Optionally, for each main program in each main program operation process, according to the actual requirements of the process configuration and the parameter information of the device to which the PLC device corresponding to the current main program belongs, with the help of a configurable configuration tool and parameter information, a subprogram of each main program is constructed, including:

[0025] Each PLC device is communicatively connected to the SCADA system, and all parameter information of upstream and downstream devices in the pharmaceutical industry is stored in the SCADA system;

[0026] The Direct system reads the parameter information of the device to which the currently used PLC device belongs from the SCADA system, and displays the read parameter information in the configurable parameter information, and constructs a subprogram of each main program with the help of the configurable configuration tool and parameter attribute information.

[0027] In a second aspect, an embodiment of the present invention further provides a server for realizing coordinated linkage of upstream and downstream devices in the pharmaceutical industry. The Direct system is integrated in the server, and the server is communicatively connected to the upstream and downstream devices in the pharmaceutical industry, and the server is communicatively connected to the server to which the MES system belongs;

[0028] The Direct system executes the method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry according to any one of the first aspects above.

[0029] Optionally, the upstream and downstream devices include: a culture medium preparation device, a cell culture device, a virus harvesting device, and a purification process device.

[0030] (III) Beneficial effects

[0031] The method of the present invention can be implemented in various processes such as traditional Chinese medicine decoction pieces workshops, preparation workshops, and biological products workshops. Without modifying the device PLC program, the Scada system is used to centrally share the data of the whole plant's equipment and provide it to the Direct system. In the Direct system, the equipment linkage programs of each production line are flexibly configured in a building block manner, so as to achieve the coordinated linkage of upstream and downstream devices.

[0032] Furthermore, the Direct system can automatically generate electronic batch records of the equipment to ensure data integrity for viewing at any time.

[0033] The method adopted by the present invention is that after Direct obtains PLC data, all newly added or modified program editing and running are executed in the Direct system without modifying the PLC program. Thus, through the flexible configuration of the above method, it is ensured that without affecting production, without the need to stop the machine, and without modifying the equipment program, the upstream and downstream devices of the production line are coordinated and linked, ensuring the compliance of production operations and the compliance with SOP procedures, and guaranteeing the quality of drugs. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic flowchart of the method for coordinating and linking upstream and downstream devices in the pharmaceutical industry provided by an embodiment of the present invention;

[0035] Figure 2 It is a schematic diagram of the system architecture to which the server integrated with the Direct system belongs provided by an embodiment of the present invention;

[0036] Figure 3 It is a schematic diagram of the main program operation process provided by an embodiment of the present invention;

[0037] Figure 4 It is a configuration diagram of the cell culture process provided by an embodiment of the present invention;

[0038] Figure 5 It is a schematic diagram of the configuration of the water addition operation step of the cell culture reactor provided by an embodiment of the present invention;

[0039] Figure 6 It is a PLC operation instruction docking configuration diagram provided by an embodiment of the present invention;

[0040] Figure 7 It is a schematic diagram of encapsulating operation step parameters and directly calling them by the MES system provided by an embodiment of the present invention;

[0041] Figure 8 It is a schematic diagram of a one - key start - stop formula program for drug production provided by an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0042] In order to better explain the present invention for easy understanding, the present invention will be described in detail below with reference to the accompanying drawings through specific embodiments.

[0043] To better understand the above technical solution, the exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a clearer and more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0044] The core idea of the method of the present invention is not to modify the automatic control programs in the upstream and downstream devices, thereby realizing the coordinated linkage of the upstream and downstream devices, which is applicable to the Chinese medicine decoction pieces, preparation and biological products workshops. At present, since each process is basically a single machine device, and the devices are independent of each other, the coordinated linkage of the upstream and downstream devices cannot be achieved. In addition, due to reasons such as the confidentiality of the process (technology) of the equipment manufacturer and the lack of professional automatic control capabilities, they are unwilling or do not have the ability to modify the program to cooperate with the pharmaceutical enterprise to realize the coordinated linkage of the upstream and downstream devices of the production line; by using the method and system of the embodiment of the present invention (hereinafter referred to as: Direct system), through flexible configuration, it is ensured that without affecting production, without the need to stop the machine, and without the need to modify the device program, the coordinated linkage of the upstream and downstream devices of the production line is realized. Further, the method of the embodiment of the present invention can also specify the electronic batch record data of the process, provide the electronic batch record of the data real-time production equipment for the pharmaceutical MES (Manufacturing Execution System), ensure the compliance of production operations and the compliance of the SOP (Standard Operation Procedure) regulations, and guarantee the quality of drugs.

[0045] The following Scada system is used to centrally share the data of each PLC device, which belongs to a general program in the pharmaceutical industry.

[0046] Embodiment 1

[0047] As Figure 1 shown, Figure 1 shows a schematic flowchart of a method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry. The execution subject of the method in this embodiment can be a server integrated with the Direct system. In this embodiment, the server integrated with the Direct system is communicatively connected to the PLC devices of the upstream and downstream devices in the pharmaceutical industry. Each PLC device in the upstream and downstream devices is independent of each other. The method may include the following steps:

[0048] S10. The editing interface of the Direct system receives the operation instructions of the user, and constructs the main program operation flow of the PLC devices of the upstream device and the downstream device by means of a configurable configuration tool;

[0049] S20. For each main program in the main program operation process, according to the actual requirements of the process configuration and the parameter information of the device to which the PLC device corresponding to the current main program belongs, with the help of a configurable configuration tool and the parameter information, construct the subprograms of each main program. Each operation step in the subprogram is a standardized step that meets the SOP operating procedures and has executable assignment information.

[0050] For example, each PLC device can be communicatively connected to the SCADA system, and all the parameter information of the upstream and downstream devices in the industry is stored in the SCADA system.

[0051] The Direct system reads the parameter information of the device to which the currently used PLC device belongs from the SCADA system, and displays the read parameter information in the configurable parameter information. With the help of a configurable configuration tool and the parameter attribute information, construct the subprograms of each main program.

[0052] S30. Receive the start instruction triggered by the user, and then execute each process based on the devices to which the PLC devices in the main program operation process belong.

[0053] Specifically, step S30 can be understood as follows: after the main program operation process and the subprogram processes of each main program are configured, the Direct system checks whether it meets the SOP operating procedures. If so, display the operation button for starting on the main interface.

[0054] After the user triggers the operation button to send a start instruction, the Direct system issues an operation instruction to the device to which the corresponding PLC device belongs through the OPC method according to the information of each process, so that the devices to which each PLC device belongs execute each process.

[0055] In the specific implementation process, the main interface of the Direct system displays the execution process information of the current process.

[0056] The above method flexibly configures the device linkage programs of each production line in the Direct system in a building-block manner without modifying the PLC program of the device, thereby realizing the coordinated linkage of upstream and downstream devices, providing convenience for the operator, and saving time and cost.

[0057] In practical applications, the above method further includes step S40 not shown in the following figure:

[0058] S40. The Direct system generates and stores the electronic batch record data of each PLC device during the process execution.

[0059] With Figure 2 shown Figure 2The system architecture to which the server integrated with the Direct system belongs is shown. In this system architecture, when the server integrated with the Direct system is communicatively connected to the MES system in the pharmaceutical industry, at this time, the MES system reads each formulation parameter and assignment information in the subroutines of each main program, and during the process execution, generates and stores the electronic batch record data of each PLC device.

[0060] In the specific implementation process, the Direct system is also used to encapsulate the configured main program operation process and the sub-processes of each main program to form a production instruction sheet. The MES system calls the production instruction sheet based on the input product and output, and realizes the issuance of process instructions to the devices to which each PLC device belongs based on the encapsulated program to execute each process.

[0061] In occasions where the automation degree of each process single-machine equipment in the traditional Chinese medicine decoction pieces workshop, preparation workshop, vaccine workshop, etc. is high, but the equipment is independent of each other, the formulation programs of each vaccine can be flexibly configured in the Direct system in a building-block manner. When the program runs, the Direct system issues instructions to the PLC device through the OPC method, just like operating on the monitoring screen of the PLC, so as to achieve the purpose of one-key start and stop of drug production, and the standardization of formulation execution.

[0062] Without affecting production, without the need to stop the machine, and without modifying the device PLC program, the above method can be programmed in the Direct system to achieve the purpose of improving the automation degree of single-machine equipment and achieving the coordinated linkage of upstream and downstream devices.

[0063] The formulation parameters and process parameters of each process in the Direct system are provided to the MES system for calling through an interface, that is, the MES system can download the formulation parameters of the product line to each process of the Direct system at one time, and at the same time, Direct can feedback the actual operation data to the MES system once after production is completed, reducing the number of interactions and ensuring the security of information and the compliance of parameters.

[0064] Embodiment 2

[0065] To better understand the steps of the method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry in the above Embodiment 1, the following combines Figure 2 and Figure 3 to elaborate on the above method in detail.

[0066] Taking the vaccine industry as an example for illustration, the vaccine industry usually has processes such as culture medium preparation, cell culture, virus harvesting, and purification. Each process is controlled by a single-machine PLC system and is independent of each other. Therefore, this embodiment provides a system architecture for realizing mutual cooperation, as Figure 2 shown.

[0067] In Figure 2 , the medium preparation, cell culture, virus harvesting and purification systems are all independent PLC devices. The independent PLC devices provide data to the Direct system through OPC data transmission. In the Direct system, the formula programs of each vaccine are flexibly configured in a building-block manner. When the program runs, the Direct system issues instructions to the PLC devices through the OPC method, just like operating on the monitoring screen of the PLC, thus realizing the one-key start and stop operation of drug production. The Direct system realizes the programming and standardization of the SOP procedure operations on the PLC screen through its own drag-and-drop and configurable configuration tools, without modifying the PLC program. The Direct configurations of the medium preparation, cell culture, virus harvesting and purification processes are basically similar. The following takes the typical process - cell culture Direct configuration as an example for elaboration.

[0068] The above OPC data transmission method can be an industrial standard based on OLE, COM and DCOM technologies (OLE for Process Control) (including a set of standards for interfaces, attributes and methods, used in process control and automation systems.

[0069] The method for coordinated linkage of upstream and downstream devices includes:

[0070] Step 1: Create the main program of YG_YM (hepatitis B vaccine), and configure the subprograms of each device for medium preparation, cell culture, and virus harvesting in a building-block manner. The configuration of the main program is as Figure 3 shown.

[0071] Step 2: Take the typical process - cell culture as an example to expand the configuration of each operation step. The operation steps of cell culture are mainly divided into 5 operation steps: adding water to the reactor, heating the reactor, sterilizing the reactor, cooling and maintaining pressure in the reactor, and culturing in the reactor. As Figure 4 shown.

[0072] Step 3: Take the operation step of adding water to the reactor as an example for elaboration, which is mainly divided into 5 steps: switching the water inlet valve & vent valve to automatic, automatically opening the water inlet valve, the flowmeter cumulative value reaching the set value, automatically closing the water inlet valve & vent valve, and recording the cumulative value of the added water volume. As Figure 5 shown.

[0073] Step 4: Configure the docking with the PLC operation instructions. Taking the switching of the water inlet valve & vent valve to automatic as an example, the Direct system can directly associate the corresponding OPC tag numbers in the PLC system and perform corresponding assignment operations, and at the same time automatically judge whether the assignment is successful. As Figure 6 shown.

[0074] Step 5: Each operation step provides corresponding recipe parameters (recipe set value SR and process feedback value FR) for direct call by the MES system, and the MES system truthfully generates electronic batch record data. As Figure 7 shown.

[0075] Step 6: On the operation interface of the Direct system, it can be directly started and stopped with one key to realize the programming and standardization of the recipe execution in pharmaceutical production. As Figure 8 shown.

[0076] In this embodiment, it is very convenient to improve the automation level of single equipment with the help of the Direct system, rather than by modifying the PLC program. Modifying the PLC program requires the equipment manufacturer to provide process secrets and cooperate with the program modification, and the operability is very poor; with the help of the Direct system, the operation mode of the operator panel can be solidified through the configuration method without modifying the equipment PLC program, truly achieving the improvement of the automation level of single equipment without affecting production and without the need to stop the machine.

[0077] Similarly, it is very convenient to realize the coordinated linkage of upstream and downstream equipment with the help of the Direct system, and to directly start the recipe execution program of the drug with one key in the Direct system. After the recipe execution is completed, the system automatically generates recipe data and process parameters and provides them for the MES system to call through the interface.

[0078] Embodiment III

[0079] The embodiment of the present invention also provides a server for realizing the coordinated linkage of upstream and downstream devices in the pharmaceutical industry. The Direct system is integrated in the server, and the server is communicatively connected to the upstream and downstream devices in the pharmaceutical industry, and the server is communicatively connected to the server to which the MES system belongs;

[0080] The Direct system executes the method for coordinating the linkage of upstream and downstream devices in the pharmaceutical industry described in any of the above embodiments.

[0081] For example, the upstream and downstream devices include: a culture medium preparation device, a cell culture device, a virus harvesting device, a purification process device, the upstream and downstream devices in a traditional Chinese medicine decoction piece workshop, the upstream and downstream devices in a preparation workshop, and the upstream and downstream devices in a biological product workshop.

[0082] It should be noted that in the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word "comprising" does not exclude the presence of elements or steps not listed in a claim. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. The present invention can be implemented by means of hardware comprising several different elements, and by means of a suitably programmed computer. In a claim listing several means, several of these means can be embodied by the same hardware item. The use of the terms first, second, third, etc. is for convenience only and does not denote any order. These terms can be construed as part of the name of the element.

[0083] In addition, it should be noted that in the description of this specification, the description of terms such as "one embodiment", "some embodiments", "embodiment", "example", "specific example" or "some examples", etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, without conflict, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0084] Although the preferred embodiments of the present invention have been described, those skilled in the art can make additional changes and modifications after learning the basic creative concepts. Therefore, the claims should be construed to include the preferred embodiments as well as all changes and modifications falling within the scope of the present invention.

[0085] Obviously, those skilled in the art can make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention should also include these modifications and variations.

Claims

1. A method for coordinated linkage of upstream and downstream devices in the pharmaceutical industry, characterized in that, The server integrated with the Direct system is communicatively connected to the PLC devices of the upstream and downstream devices in the pharmaceutical industry. Each PLC device in the upstream and downstream devices is independent. Without modifying the PLC device program, the SCADA system is used to centrally share the data of all plant devices and provide it to the Direct system. The method includes: The editing interface of the Direct system receives the user's operation instructions and constructs the main program operation processes of the PLC devices of the upstream and downstream devices with the help of configurable configuration tools. For each main program in each main program operation process, according to the actual requirements of the process configuration and the parameter information of the device to which the PLC device corresponding to the current main program belongs, with the help of configurable configuration tools and parameter information, a subprogram of each main program is constructed. Each operation step in the subprogram is a standardized step that meets the SOP operating procedures and has executable assignment information. Each PLC device is communicatively connected to the SCADA system, and all parameter information of the upstream and downstream devices is stored in the SCADA system. The Direct system reads the parameter information of the device to which the currently used PLC device belongs from the SCADA system and displays the read parameter information in the configurable parameter information, and constructs the subprogram of each main program with the help of configurable configuration tools and parameter attribute information. Upon receiving the start instruction triggered by the user, each process is executed based on the devices to which the PLC devices belonging to each main program operation process belong.

2. The method according to claim 1, wherein The method further includes: The Direct system generates and stores the electronic batch record data of each PLC device during the execution of the process.

3. The method according to claim 1 or 2, characterized in that, When the server integrated with the Direct system is communicatively connected to the MES system in the pharmaceutical industry, the method further includes: The MES system reads each formulation parameter and assignment information in the subprogram of each main program, and generates and stores the electronic batch record data of each PLC device during the execution of the process.

4. The method according to claim 3, characterized in that, Upon receiving the start instruction triggered by the user, each process is executed based on the devices to which the PLC devices belonging to each main program operation process belong, including: The Direct system encapsulates the configured main program operation process and the subprogram processes of each main program to form a production order form. The MES system realizes the issuance of process instructions to the devices to which each PLC device belongs based on the encapsulated program by calling the production order form to execute each process.

5. The method according to claim 1, characterized in that, Upon receiving the start instruction triggered by the user, each process is executed based on the devices to which the PLC devices belonging to each main program operation process belong, including: After the main program operation process and the subprogram processes of each main program are configured, the Direct system checks whether they comply with the SOP operating procedures. If so, an operation button for starting is displayed on the main interface. After the user triggers the operation button to issue a start instruction, the Direct system issues an operation instruction to the device to which the corresponding PLC device belongs through the OPC method according to the information of each process, so that the devices to which each PLC device belongs execute each process.

6. The method according to claim 5, wherein The method further includes: The main interface of the Direct system displays the execution process information of the current process.

7. A server for realizing coordinated linkage of upstream and downstream devices in the pharmaceutical industry, characterized in that, The server integrates a Direct system, and the server is communicatively connected to the upstream and downstream devices in the pharmaceutical industry, and the server is communicatively connected to the server to which the MES system belongs; The Direct system executes the upstream and downstream device coordinated linkage method in the pharmaceutical industry according to any one of claims 1 to 6 above.

8. The server according to claim 7, wherein The upstream and downstream devices include: a culture medium preparation device, a cell culture device, a virus harvesting device, a purification process device, the upstream and downstream devices in a traditional Chinese medicine decoction pieces workshop, the upstream and downstream devices in a preparation workshop, and the upstream and downstream devices in a biological products workshop.

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