KR100853318B1 - Device and method for carrying out the decentralized production of desired products from different starting materials, and an automated process system - Google Patents

Abstract

The present invention relates to an apparatus and a method for the dispersion manufacturing of requested products and automated process systems consisting of different raw materials. According to the invention, the manufacture of the requested product 1 takes place in at least one distributed batch automated process system which processes the raw material 2 prepared according to the recipe data 25 provided into each requested product 2. . The process system 3 is connected to the central remote computer 28 by a communication medium 27. Similarly an input device 22 connected to the communication medium 27 is used for the input of the product request 37. The central computer 28 obtains the recipe data 25 necessary for manufacturing the requested product 1 from the recipe data storage for the automated process system 3 in accordance with the received product request 37 or The recipe data is passed to the process system. The individual manufacturing process of the product 1 is logged in the central remote device 28 with respect to the process data 13 'relating to quality and quantity.

Description

DEVICE AND METHOD FOR CARRYING OUT THE DECENTRALIZED PRODUCTION OF DESIRED PRODUCTS FROM DIFFERENT STARTING MATERIALS, AND AN AUTOMATED PROCESS SYSTEM}

In the field of chemistry, pharmacy, medicine, biology or cosmetology, products which are formulated according to different formulations from different raw materials for different applications and for different people are often only needed in relatively small quantities. An example of this is the case of administering to the patient a patient-specific formulations or combinations thereof upon patient or at each occurrence. Given that these products are individually prepared in small quantities, the central production of such products and the sale to the end customers are very complex and uneconomical. In another aspect, only one or a few manufacturers can use the knowledge, in particular the formulation, to manufacture individual products as patent holders or licensees. In addition, specified safety and / or quality requirements should be observed when manufacturing large quantities of products. This applies in particular in the preparation of pharmaceuticals which must be supplied in prescribed quality and composition only to authorized persons such as pharmacists, physicians or patients.

The object of the present invention is to realize the simple and economical manufacture of different preparations in view of the problems raised above.

According to the invention this object is achieved by the device as set forth in claim 1 or as an alternative, the automated process system as set forth in claim 20 and the method as set forth in claim 21.

Advantageous refinements of the solution according to the invention are disclosed in the dependent claims.

The measures according to the invention shorten the conventional process chain from the manufacturer to the distributor to the end customer.

This object is achieved by the production of different required products in a distributed, locally arranged, automated process system capable of processing the raw material provided into the respective desired product according to the supplied recipe data. Examples of such automated process systems are known from prior German patent applications 199 54 855.2 and 100 15 423.9. The process system known in the above documents is formed of configurable process modules which process each predetermined partial process in an automated manner, which process modules are connected to the upper control device via a data circuit. Process modules are used, for example, of different types of reactor modules, including micro reactors, pump modules, filter modules, power modules, fluid supply and discharge modules, analysis modules and the like. The term "setting" refers to the parameterization of individual process modules as well as the arrangement and interconnection of said process modules. In this case, the connection of the process modules also includes the exchange of material to be processed between the respective process modules.

In addition, the recipe data needed to manufacture the requested product is obtained or relayed by the computer after the product request has been delivered to a remote central computer and transmitted to the automated process system. The term central here means that at least one distributed process system can use a remote computer just like any other distributed process system at another point to obtain the required recipe data. The product request can be entered into the input device in the form of a product name, chemical formula, general basic formulation, etc., for example by direct reading of the dosage form of the patient card or via a user dialog. It is also possible to specify the requested product in talk mode with a remote central computer. The recipe data determined at the product request and sent to the process system, in the most common case, includes all the information relating to the requested product preparation, in particular the necessary raw materials, the necessary manufacturing steps and process parameters such as the amount of material, flow or temperature. According to this information, the process system is trained to manufacture the requested product. Therefore, in the case of the above-mentioned modular process system, each required process module is selected and set. In this case, for example, the process parameters are automatically set based on the recipe data transmitted from each process module, so that the setting can be made at least partially automatically. The process system can also automatically select and process the required raw materials from a number of different raw materials supplied according to the information on the required raw materials contained in the recipe data. When settings such as the selection of the individual process modules required and the wiring of the modules are made manually, for example, the accuracy of the actual settings carried out individually can be checked on the basis of the target settings preset by the recipe data.

As a preferred communication medium for data exchange between a distributed process system and a central remote computer, the Internet, i.e. a global computer network configured to enable communication between computers, is used. This is based on the Client-Server principle, which provides a service that can be invoked by one computer by another. Access to the Internet server is made with the help of known Internet browsers, and communication within the Internet is made using the provided Internet protocols. The Internet service may optionally connect (log in) to another computer (Host) for the conversation mode after checking for access rights, download data from the computer, and recall the owned data. It also includes the possibility to upload to a computer or perform operations on a remote computer. Other communication media may be used instead of the Internet or intranet.

The central computer accesses a recipe data storage comprising recipe data for a plurality of different products in accordance with a product request received corresponding to the first alternative, to select at least one recipe data set for the requested product. The recipe data of the recipe data set is transmitted to a process system. The recipe data storage device may be distributed into a plurality of recipe data banks, which may in turn work with other computers assigned thereto, for example computers of different chemical companies or pharmaceutical companies. In this case, the central computer connected by the distributed process system can access their recipe data bank through communication media and other computers to obtain the recipe data.

In a second alternative, the central computer relays the product request sender to one or more distributed recipe data banks that contain the recipe data set for the requested product, rather than providing the required recipe data by itself. In this case, an additional transaction is made between the process system and each relayed recipe data bank for transferring the appropriate recipe data to the process system.

In order to ensure the dissemination of the used raw materials, the automated process system comprises a device for managing raw material inventory, preferably connected with a data interface. Thus, when inventory levels are nearly low, the process system can automatically execute additional orders for raw materials required by the manufacturer via the data interface. The manufacturer provides this service through a computer connected to the communication medium.

For example, in the case of pharmaceuticals, in order to meet specified safety requirements and to bill the service charges performed in connection with the acquisition of recipe data, the central computer preferably performs the authority check and / or certification of the sender of the product request. A device for calculating the service charges performed in connection with the acquisition of the recipe data, including a device for the case and, in some cases, a necessary license fee. If the central computer performs only a partial service, for example by relaying the querying system to a distributed recipe data bank, the distributed recipe data bank also has a device for authorization checking and / or authentication and a device for calculating the service charges performed. Can be provided. In a central remote computer, the sender of a product request usually refers to an individual process system. Identity and authorization checks of the person entering the product request may be performed by the input device itself.

For quality assurance and / or license fee calculation, preferably, the process system automatically detects process data related to the quality and / or quantity of the manufactured product, and the process data is transmitted via a central computer and preparation method via a data interface and communication medium. Transfer to the recipe data bank that provides the data. The process data is appropriately evaluated and stored in the recipe data bank.

In summary, a local device is used in the process system of the device according to the present invention, in which the requested product from a predetermined number of raw materials can be prepared according to individual recipes, and the local device is a user interface (input device). ) And provider interface (data interface). In this case, when the customer is identified in the user interface and enters a product request, the supplier interface establishes contact with the licenser, the manufacturer of the required raw material and the closing point for the requested product. Also provided is an apparatus for quality control and documentation of transactions.

Next, the present invention will be described with reference to the embodiments shown in the drawings.

A modular automated process system 3 is provided to disperse a product (1) currently needed from liquid and / or gaseous raw materials (2), here a liquid phase, which is for example a laboratory, Distributed in pharmacies or hospitals. Another process system 3 ', 3' 'of the same type may be present in a number of different places. The process system 3 consists of different process modules 4 to 9 which can be connected in series, in which part processes for manufacturing the product 1 requested in the process modules 4 to 9 are automatically executed. Different types of reactor modules, pump modules, filter modules, power modules, fluid supply and discharge modules, analysis modules, etc. may be used as the process modules 4 to 9, for example. The active process modules 4, 6, 7, 9 executing the partial process each have one control unit 10 and a fluid unit 11, the inherent partial process in the fluid unit 11 being the control unit. It is executed in accordance with the control signal 12 of (10). The process signal 13 received at the fluid unit 11, ie the temperature value, pressure value or analysis value, is transmitted to the control unit 10. The control units 10 provided in the different process modules 4 to 9 are connected to each other via a data bus 14 and a power bus 15. The fluid units 11 are connected to each other via a fluid bus 16, which consists of a plurality of channels 17, raw material 2 to be processed through the plurality of channels 17. And in some cases intermediate products are conveyed. These channels 17 extend in parallel in the active process modules 4, 6, 7, 9, with channels 17 of two adjacent active process modules (here 4 and 6 and 7 and 9 respectively). Wiring out of this parallel structure and individually wired is made possible by inserting passive process modules 5 and 8 with appropriately fixed channel configurations in the middle. As an alternative to this, the wiring of the channels 17 can also be made controllable by means of an active process module inserted in between, the fluid unit of the process module being formed as a channel matrix, for example with a controllable valve.

The process module 4 is used to supply the basic functions for the process system 3. For this purpose, the control unit 10 is connected to an external power supply 18, to the upper control device 20 having the display device 21 and the input device 22 via a data circuit 19, for example an external bus. do. As an alternative to this, the data circuit 19 may be formed as a direct extension of the data bus 14.

As schematically shown, the data bus 14, the power bus 15 and the fluid bus 16 each consist of internal bus sections provided inside the process modules 4-9 connected in series on a common carrier 23. And the buses 14 to 16 are formed by installing the necessary individual process modules 4 to 9 on the carrier 23.

The process modules 4 to 9 are capable of both internal and external settings. Internal settings in particular comprise parameterization of the process modules 4 to 9, wherein the parameter values are passed from the upper control device 20 via the data circuit 19 and the data bus 14 to the individual process modules 4 to 9. May be sent to a control unit 10 within. The settings in the process modules 4 to 9 can also be executed manually by the operation control element 24. The external setting here means that the individual process modules 4 to 9 are coupled to the process system 3. This external setting also includes wiring the channel 17 between adjacent process modules in addition to the selection and sequence of the process modules 4 to 9. If the channel 17 should not extend in parallel between two adjacent process modules, for example 4 and 6, as already mentioned above, this will result in the intermediate insertion of the passive process module 5 by the corresponding channel setting. Is done through. All information concerning the internal and external settings of the individual process modules 4 to 9 is stored in a setting indicator (not shown) inside the individual control unit 10, and the information is stored from the setting indicator to the data bus ( 14 and through the data circuit 19 can be called by the upper control device 20.

Examples of the automated process system 3 described so far have already been the subject of German patent applications 199 54 855.2 and 100 15 423.9.

In order to manufacture each requested product 1 in the process system 3 the supply of the raw material 2 necessary on the one hand, the specific internal and external settings of the process modules 4 to 9, and finally the process module In processing the raw material 2 in the fluid unit 11 of 4 to 9, a special process sequence is required. In this case, the general process sequence is controlled by the upper control device 20 and the partial processes in the fluid unit 11 are controlled by the assigned control units 10. All the information necessary for this is the recipe data 25 of the product 1 to be manufactured. In order to access this recipe data 25 the process system 3 is connected to a data interface 26 connected to the data circuit 19 for data exchange with the central computer 28 via a communication medium 27 (here, the Internet). ). The central computer 28 can access a recipe data storage device comprising recipe data of a number of different products, the recipe data storage device having a unique recipe data bank 30 and different information providers (here for example chemistry). It may be distributed to additional recipe data banks 31, 32, 33 of other computers 34, 35, 36 held by a company or pharmaceutical company. In the input device 22 of the distributed batch processing system 3, a product request 37 related to the product 1 currently required is input through a user dialogue. In this case, by inserting the chip card 41 into the card reader 42 in the input device 22, the person who inputs the product request 37 is authenticated. Alternatively, the card reader 42 may read the product request 37 of the patient card 43. The product request 37 is subsequently sent to the central computer 28 via the data interface 26, which is adapted to at least one recipe data for the product 1 requested from the recipe data storage device. The set is selected and the recipe data 25 contained in the recipe data set is transmitted via the communication medium 27 to the process system 3. To this end, the central computer 28 can access the recipe data banks 31 to 33 by other computers 34 to 36, and obtain recipe data 25 from the recipe data banks 31 to 33. Can be. As an alternative to this, the central computer 28 detects a suitable external data bank (eg 32) based on the product request 37 and converts the recipe data bank between the computer (eg 35) and the process system 3 of that data bank. The connection for transferring the recipe data 25 selected from (32) directly to the process system 3 via the computer 35 is relayed. The recipe data 25 is provided with a display device 21 such that the necessary raw material 2, the necessary process modules 4 to 9 and information on the arrangement and parameterization of the process modules are provided to the operator of the process system 3. Displayed on the screen. If automatic setting of the individual process modules 4 to 9 is possible, the recipe data 25 can be automatically transmitted to the associated control unit 10. The recipe data 25 containing the unique process sequence for the manufacture of the product 1 is automatically transmitted to the upper control device 20, which in turn sends the data necessary for the partial process to the individual process modules ( 4 to 9 to the control unit 10 of the transfer.

The selection and arrangement of the necessary process modules 4 to 9, and their settings, carried out according to the recipe data 25, is carried out via a setting display device in the control unit 10 of the process modules 4 to 9. By being transmitted to (20), an inspection of the actual setting executed in relation to the target setting of the process system (3) preset by the recipe data (25) in the control device (20) can be made, and the process system (3) Errors in the structure or parameterization of the individual process modules 4 to 9 can be detected and displayed on the display device 21. If the error detected in the structure or parameterization is not corrected, the entire process in the process system 3 is interrupted and the fact is notified to the central computer 28.

The central computer 28 comprises a device 38 (here process system 3) for authority check and / or authentication of the sender carrying the product request 37. The central computer 28 also has a device 39 for calculating the service charge performed in connection with the acquisition of the recipe data 25, which device is from a so-called 'e-commerce' solution or an 'e-business' solution. As is known in the art, the other computers 34 to 36 likewise have a corresponding device 39 for calculating the service charges carried out by them.

As mentioned above, the process signal 13 received at the fluid unit 11 during the process sequence for the manufacture of the product 1 is transmitted to the control unit 10 in the individual process modules 4-9, where From the upper control device 20. Process data 13 ′ relating to the quality and / or quantity of the product 1 manufactured from the control device 20 is transmitted via the data interface 26 to the central computer 28, the central computer 28. Stores the data 13 ′ in storage device 40 for documentation of the quality and / or quantity of manufactured product 1. Corresponding to the documented quantity of the manufactured product 1, the central computer 28 may calculate royalties in connection with the service fee calculation. In addition, the manufactured data 1 can be printed by the printer 44 in the distributed process system 3 with relevant data, in particular receipt data for the end customer of the product 1.

The upper control apparatus 20 of the process system 3 has an apparatus 45 for managing the stock of the raw material 2. When a specific stock (2) is newly required, or at the time of manufacture of the product (1), if it is below the predetermined minimum stock of the raw material (2), or according to the recipe data (25) obtained for the individual product (1) to be prepared. When it is determined that the inventory amount is insufficient according to the detected process data 13, the device 45 is connected to the communication medium via the communication medium 27, and the computer 46 of the manufacturer providing the corresponding Internet service. ) Will automatically fulfill further orders of the relevant raw materials.

Claims (27)

Apparatus for dispersing the requested product from different raw materials, At least one distributed batch automated process system for processing the supplied raw material into each requested product in accordance with the provided recipe data; A central computer remotely located away from the automated process system; A data interface associated with the automated process system for exchanging data with the central computer via a communication medium; And An input device connected to the data interface and to which a product request is input; Including, The central computer receives the product request, accesses a recipe data storage device containing a plurality of sets of recipe data for a plurality of different products, selects at least one recipe data set that meets the product request, and Transmitting recipe data contained in a recipe data set to the automated process system via the communication medium, Dispersion manufacturing device. The method of claim 1, A plurality of discrete recipe data banks in which the recipe data storage device is distributed; At least one additional computer associated with at least one of the recipe data banks; And Allow the central computer to access the additional computer and the recipe data bank associated with the additional computer; Including, Dispersion manufacturing device. The method of claim 1, The communication medium comprises a network, Dispersion manufacturing device. The method of claim 3, The network comprises the Internet, Dispersion manufacturing device. The method of claim 1, Wherein said automated process system automatically selects a feedstock from a stock of available feedstocks based on information contained in said recipe data in relation to available feedstocks and supplies said feedstock into said automated process system, Dispersion manufacturing device. The method of claim 1, The automated process system includes an apparatus connected with the data interface to manage inventory of available raw materials, Dispersion manufacturing device. The method of claim 1, The central computer includes a device for checking at least one of a sender's authority and identity to forward the product request, Dispersion manufacturing device. The method of claim 1, The central computer includes an apparatus for calculating a service charge incurred in connection with the transmission of the recipe data; Dispersion manufacturing device. The method of claim 1, The automated process system automatically generates process data relating to at least one of the quality and quantity of the requested product, and transmits the process data to the central computer that provided recipe data via the data interface and the communication medium, Dispersion manufacturing device. The method of claim 1, Processing the raw material into the requested product includes converting the raw material into the requested product by providing the raw material to a manufacturing process, Dispersion manufacturing device. The method of claim 1, The automated process system generates the requested product from the raw material, Dispersion manufacturing device. Apparatus for dispersing the requested product from different raw materials, At least one distributed batch automated process system for processing the supplied raw material into each requested product in accordance with the provided recipe data; A central computer remotely located away from the automated process system; Additional computers disposed remotely from the automated process system and each having an associated recipe data bank containing recipe data for a plurality of different products; A data interface associated with the automated process system for exchanging data with the central computer and the additional computers via a communication medium; And An input device connected to the data interface and to which a product request is input; Including, The central computer receives the product request, selects at least one recipe data bank containing recipe data suitable for the product request, and transmits the recipe data included in the recipe data set of the selected recipe data bank to the communication medium and Establish a connection between additional computers associated with the automation system for transmission to the automation process system via the data interface, Dispersion manufacturing device. The method of claim 12, The communication medium comprises a network, Dispersion manufacturing device. The method of claim 13, The network comprises the Internet, Dispersion manufacturing device. The method of claim 12, Wherein said automated process system automatically selects a feedstock from a stock of available feedstocks based on information contained in said recipe data in relation to available feedstocks and supplies said feedstock into said automated process system, Dispersion manufacturing device. The method of claim 12, The automated process system includes an apparatus connected with the data interface to manage inventory of available raw materials, Dispersion manufacturing device. The method of claim 12, The central computer includes a device for checking at least one of a sender's authority and identity to forward the product request, Dispersion manufacturing device. The method of claim 12, Each of the central computer and the additional computers includes an apparatus for calculating a service charge incurred in connection with the transmission of the recipe data; Dispersion manufacturing device. The method of claim 12, The automated process system automatically generates process data relating to at least one of the quality and quantity of the requested product, and transmits the process data to a computer that provided recipe data via the data interface and the communication medium, Dispersion manufacturing device. Process parts for processing the supplied raw material into the requested product according to the provided recipe data; An input device for inputting a product request; And A data interface for sending the product request to a remotely located central computer and for receiving the recipe data from the central computer or from another remote computer relayed by the central computer; Including, Automated process system. A method for dispersing a requested product from a raw material in at least one automated process system, Sending a product request input to an input device in a distributed automated process system via a data interface to a centrally located remote computer remote from the automated process system; Receiving, via the data interface, recipe data supplied from the central computer or supplied by operation of the central computer; And Processing the raw material into the requested product according to the recipe data; Including, Dispersion Manufacturing Method. The method of claim 21, The recipe data is selected from a set of recipe data sets stored in various data banks, the recipe data is selected according to the product request, and includes information needed to generate the requested product, Dispersion Manufacturing Method. The method of claim 21, The recipe data includes manufacturing instructions for the automated process system to manufacture the requested product, Dispersion Manufacturing Method. The method of claim 21, The recipe data guides the automated process system in producing the requested product, Dispersion Manufacturing Method. The method of claim 21, The requested product is produced from a predetermined number of raw materials, the predetermined number being identified in the recipe data, Dispersion Manufacturing Method. The method of claim 21, The automated process system includes at least one active module that performs at least a portion of the step of processing the raw material into the requested product. Dispersion Manufacturing Method. The method of claim 26, The automated process system comprises at least one passive module, the at least one active module comprising a fluid unit and a control unit, Dispersion Manufacturing Method.

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